Department of Health | Medical Device Division - In-Vitro Diagnostic Medical Devices for COVID-19 NOT Listed Under MDACS (from 1 January 2022)

Safety Alert Summary

Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade, other regulatory jurisdictions as well as the World Health Organization. It only serves as a reference and should not be considered as exhaustive and up-to-date information. Please contact manufacturer or local supplier for details.

Caption: Safety Alert Summary
Posting Date	Description of Product	Source of Information *
29 Nov 2024	29 Nov 2024Exact Diagnostics LLC (Sponsored by Bio-Rad Laboratories Pty Ltd) Exact Diagnostics SARS-CoV-2, Flu, RSV Positive Run Control (COVFLU) [Catalog Number: COVFLU; UDI: 00812242030901; Lot Numbers: 64617184, 64609574; Expiry Dates: 30/04/2026, 31/03/2026]	29 Nov 2024TGA
17 Oct 2024	17 Oct 2024CUE HEALTH INC Cue Health COVID-19 Test Cartridge	17 Oct 2024FDA
17 Oct 2024	17 Oct 2024UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication	17 Oct 2024FDA
14 Oct 2024	14 Oct 2024Luminex Molecular Diagnostics Inc 1) NxTAG Respiratory Pathogen Panel [REF: I051C0447]; 2) NxTAG Respiratory Pathogen Panel +SARS-CoV-2 [REF: I056C0468]	14 Oct 2024FDA
30 Sep 2024	30 Sep 2024FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD DVOT SARS-CoV-2 ANTIGEN TEST KIT, DVOT SARS-Cov-2 & Influenza A+B Antigen Combo Test Kit, DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit	30 Sep 2024FDA
27 Sep 2024	27 Sep 2024Cepheid Xpert Xpress CoV-2/Flu/RSV plus	27 Sep 2024TGA
14 May 2024	14 May 2024Do Not Use Cue Health's COVID-19 Tests Due to Risk of False Results: FDA Safety Communication	14 May 2024FDA
13 May 2024	13 May 2024Becton Dickinson and Company BD SARS-CoV-2 Reagents for BD MAX Systems	13 May 2024TGA
05 Apr 2024	05 Apr 2024Product Defect Correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - Potential for control line variability	05 Apr 2024TGA
18 Mar 2024	18 Mar 2024Hangzhou Fanttest Biotech Co Ltd (Sponsored by Australia Health Products Central Pty Ltd) Fanttest COVID-19/lnfluenza A&B Antigen Test Kit	18 Mar 2024TGA
22 Feb 2024	22 Feb 2024Sonictec Pty Ltd Fanttest COVID-19/Influenza A&B Antigen Test Kit [Product Identifiers: I2210004 to I2210006, I2212002 to I2212006 and all batches after; Expiry Date: 09/2023 to 05/2025]	22 Feb 2024TGA
16 Feb 2024	16 Feb 2024Quidel Corporation Sofia 2 Flu + SARS Antigen FIA [UDI-DI: 30014613339229; Lot number : 709083]	16 Feb 2024FDA
25 Jan 2024	25 Jan 2024Hologic, Inc. PANTHER FUSION System REF 912101000	25 Jan 2024FDA
19 Jan 2024	19 Jan 2024PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 Rapid Antigen At-Home Test [REF: P0040; Lot: 22S0388-R01]	19 Jan 2024FDA
23 Nov 2023	23 Nov 2023Cepheid Xpert Xpress CoV-2/Flu/RSV plus [Single Registration Number (SRN): US-MF-000010979; Unique Device Part Number Identifier (UDI): 07332940008000; Part Number: XP3COV2/FLU/RSV-10; All batch number, lot number]	23 Nov 2023MHRA
21 Nov 2023	21 Nov 2023Abbott Rapid Diagnostics Pty Ltd ID NOW Instrument. An in vitro diagnostic medical device (IVD) [Part Number: NAT-000, NAT-000S; All serial numbers]	21 Nov 2023TGA
17 Nov 2023	17 Nov 2023Pulse Oximeter Accuracy and Limitations: FDA Safety Communication	17 Nov 2023FDA
25 Sep 2023	25 Sep 2023Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022	25 Sep 2023FDA
24 Jul 2023	24 Jul 2023Qiagen GmbH QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD [REF 691223; GTIN: 14053228038846 LOT Number: 175010712; Affected Serial numbers (SNs) are from 330559516 to 330559783]	24 Jul 2023FDA
07 Jul 2023	07 Jul 2023NeuMoDx Molecular Inc NeuMoDx SARS-CoV-2 Assay - IVD [Lot Number: 123909 Exp. Date: 08-Dec-2023]	07 Jul 2023FDA
07 Jun 2023	07 Jun 2023QIAGEN QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691214, GTIN 14053228038877 [Lots: 172043034, 172043348, 172043349, 172043369, 172044712, 172046775, 172048091, 172048381, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669]	07 Jun 2023MHRA
06 Jun 2023	06 Jun 2023Becton Dickinson & Co. BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B [Catalog Number: 256088; Multiple lot numbers]	06 Jun 2023FDA
06 Jun 2023	06 Jun 2023Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test [Reference Number: 691223]	06 Jun 2023FDA
31 May 2023	31 May 2023ALLTEST Covid-19 Antigen Rapid Test (Oral Fluid) [ICOV-802H] and ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab) [INCP-502H]	31 May 2023DH
05 May 2023	05 May 2023SD Biosensor, Inc. Pilot COVID-19 At-Home Tests	05 May 2023FDA
10 Feb 2023	10 Feb 2023Diasorin Molecular LLC Simplexa Covid-19 Direct [Model or Catalog Number: MOL4150; Lot or Serial Number: 13967N, 13968N, 15061N, 13330N, 13331N, 14016N, 13336N]	10 Feb 2023Health Canada
10 Feb 2023	10 Feb 2023Diasorin Molecular LLC Simplexa Covid-19 & Flu A/B Direct [Model or Catalogue Number: MOL4250; Lot or Serial Number: 15058N, 15951N]	10 Feb 2023Health Canada
30 Jan 2023	30 Jan 2023Universal Meditech Inc. 1) Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT; 2) SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING [Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q]	30 Jan 2023FDA
13 Dec 2022	13 Dec 2022Detect, Inc. Detect Covid-19 Test [Lot Numbers: HB264, HY263, HY264]	13 Dec 2022FDA
09 Dec 2022	09 Dec 2022Dewei Medical Equipment Co. Dewei Medical Equipment Co. DNA/RNA Preservation Kits [Product Catalog Number: DW-80005-1B; Distribution Dates: May 2020 to January 2022]	09 Dec 2022FDA
01 Dec 2022	01 Dec 2022GS Biomark LLC CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers / Lot Numbers: BC-DK0200 / 42821005 BM-AD4K0200 / 110421005, 110121005, 62322004 BM-ADK0200 / 110121003 BM-CDK0200 / 110121004 BM-CFDK0200 / 110121006 BM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001 BM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002 BM-DK0600 / 110521002, 10722003, 12122004 BM-DK0800 / 12722006 BM-DK1200 / 120221002, 50222002 BM-DK1400 / 92421002, 101821005, 32222004 BM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001	01 Dec 2022FDA
28 Oct 2022	28 Oct 2022LumiraDx LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit [Catalog #: L016080109002 (EUA); LQC Kit: 2002204017; Positive Control Vial: 1000 1710 0014 0141; Negative Control Vial: 1000 1720 0014 0142; Exp. Date: 01-Mar-2023]	28 Oct 2022FDA
19 Oct 2022	19 Oct 2022American Contract Systems, Inc. COVID Test Kit Nonsterile [1) UDI-DI: Product Code: AHCV18A, Lots 980221 (exp. 01/20/2023) and 974221 (exp. 01/25/2023) 2) UDI-DI: Product Code: AHCV18B, Lots 868221 (exp. 05/31/2023), 842221 (exp. 05/31/2023)]	19 Oct 2022FDA
19 Oct 2022	19 Oct 2022LUMINOSTICS, INC dba CLIP HEALTH Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 [Lots: CC-10094-A, CC-10115-A, CC-10123-A, CC-10129-A, CC-10136-A, CC-10144-A, CC-10148-A, CC-10166-A, CC-10168-A, CC-10168-B, CC-10189-A, CC-10193-A, CC-10300-A, CC-10328-A, CC-10329-A, CC-10330-A, CC-10361-A, CC-10364-A, CC-10365-A, CC-10368-A, CC-10369-A, CC-10395-A, CC-10396-A, CC-10397-A, CC-10398-A, CC-10399-A, CC-10439-A, CC-10440-A, CC-10440-B, CC-10441-A, CC-10441-B, CC-10609-A, CC-10609-B, CC-10611-A, CC-10613-A, CC-10615-A, CC-10654-A, CC-10667-A, CC-10710-A, CC-10710-B, CC-10712-A, CC-10714-A, CC-10714-B, CC-10725-A, CC-10727-A, CC-10729-A, CC-10766-A, CC-10768-A, CC-10809-S, CC-10811-S, CC-10874-A, CC-10874-B, CC-10874-C, CC-50002-S, CC-50003-S, CC-50004-S Expiration Dates: expiry.clipcovid.com]	19 Oct 2022FDA
13 Oct 2022	13 Oct 2022Jiangsu Well Biotech Co., Ltd COVID-19 Ag Rapid Test Devices	13 Oct 2022FDA
05 Oct 2022	05 Oct 2022Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883]	05 Oct 2022MHRA
30 Sep 2022	30 Sep 2022Luminex Corporation ARIES SARS-CoV-2 Assay [Part No.: 50-10047; Lot Number (Expiry Date): AB4723A (05/25/2022); AB5041A (05/25/2022); AB5060A (06/01/2022); AB5061A (06/06/2022); AB5081A (06/07/2022); AB5139A (09/10/2022); AB5141A (09/16/2022); AB5263A (09/27/2022); AB5282A (10/05/2022)]	30 Sep 2022Firm
14 Sep 2022	14 Sep 2022Abbott Molecular, Inc. Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use. [Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085]	14 Sep 2022FDA
25 Aug 2022	25 Aug 2022Assure Tech. Co. Ltd. Ecotest Covid-19 Antigen Rapid Test Device [model/catalogue: COV-S23002; Lot/serial: I2201505]	25 Aug 2022Health Canada
24 Aug 2022	24 Aug 2022Luminex Corporation ARIES SARS-CoV-2 Assay [Lot: AB4042A]	24 Aug 2022FDA
12 Aug 2022	12 Aug 2022At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication	12 Aug 2022FDA
10 Aug 2022	10 Aug 2022Haimen Shengbang Laboratory Equipment Co. Ltd Viral Transport Media Containers [Brand names HXBL, WETEX, or Genesis Biomedical, with part numbers HX-K59, HX-K59-1, and “custom made” (saline); All lots]	10 Aug 2022FDA
08 Aug 2022	08 Aug 2022Counterfeit COVID-19 antigen rapid test kits found in Ontario	08 Aug 2022Health Canada
02 Aug 2022	02 Aug 2022North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits	02 Aug 2022FDA
27 Jul 2022	27 Jul 2022LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip, LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control [Catalog No. L017000109024, L017080109002; Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), 5000676 (Exp. 25-Aug-2022), 2002201428 (Exp. 01-Sept-2022)]	27 Jul 2022FDA
20 Jul 2022	20 Jul 2022Ortho-Clinical Diagnostics, Inc. Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960 [UDI-DI :10758750034413. All expired, in-date and future released lots]	20 Jul 2022FDA
06 Jun 2022	06 Jun 2022All Clean Natural Ltd. Surestrips Covid-19 Antigen Test [A03-50-422; 22010039, 22010040, 22010002, 21120019, 22010002, 22020004]	06 Jun 2022Health Canada
06 Jun 2022	06 Jun 2022All Clean Natural Ltd. Surestrips Rapid Response Covid-19 Antigen Rapid Test Device [Model or Catalogue Number: COV-19C25; Lot or Serial Number: 21100017]	06 Jun 2022Health Canada
18 May 2022	18 May 2022PROTERIXBIO ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit [No model number; Lots were not coded. All product will be recalled]	18 May 2022FDA
18 May 2022	18 May 2022USA Medical, LLC Diagnostic Kit SARS-cCo V Antigen Rapid Test [Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None]	18 May 2022FDA
17 May 2022	17 May 2022Woodside Acquisitions Inc Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)	17 May 2022FDA
11 May 2022	11 May 2022SML Distribution, LLC Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), may also be called Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test [All lots: UL-AG-2110-05-Q, UL-AG-2111-02-Q, UL-AG-2112-01-Q, UL-AG-2112-02-Q, UL-AG-2201-03-Q]	11 May 2022FDA
10 May 2022	10 May 2022Mesa Biotech, Inc. Accula SARS-CoV-2 Test [Product Codes: QJR; REF: COV4100; Code Information UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016, P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017, P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019, P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011; Manufactured Dates: 30 Dec 2021 to 1 Jan 2022; 15 Jan 2022 to 23 Jan 2022]	10 May 2022FDA
29 Apr 2022	29 Apr 2022R-Biopharm Pty Ltd Control LQ COVID-19 IgG + IgM [K087M-6 Lot 06840]	29 Apr 2022TGA
26 Apr 2022	26 Apr 2022Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883]	26 Apr 2022MHRA
06 Apr 2022	06 Apr 2022Seegen Allplex SARS-CoV-2 Variants II Assay [Product Code: RV10305X; All lots]	06 Apr 2022MHRA
21 Mar 2022	21 Mar 2022Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication	21 Mar 2022FDA
02 Mar 2022	02 Mar 2022ACON Laboratories, Inc. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)	02 Mar 2022FDA
02 Mar 2022	02 Mar 2022Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Test	02 Mar 2022FDA
25 Feb 2022	25 Feb 2022COVID-19 rapid antigen test kits and potential exposure to hazardous substances	25 Feb 2022Health Canada
22 Feb 2022	22 Feb 2022Hangzhou Testsea Biotechnology Co Ltd (sponsored by Australia Health Products Central Pty Ltd) Cellife Covid 19 Antigen Test Cassette pack of 5. An in vitro diagnostic medical device (IVD) [Batches: TL2A23, TL2A24, TL2A25, TL2A26 & TL2A27]	22 Feb 2022TGA
07 Feb 2022	07 Feb 2022E25Bio COVID-19 Direct Antigen Rapid Test	07 Feb 2022FDA
07 Feb 2022	07 Feb 2022SD Biosensor, Inc STANDARD Q COVID-19 Ag Home Test	07 Feb 2022FDA
31 Jan 2022	31 Jan 2022Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test [All lot codes]	31 Jan 2022FDA
12 Jan 2022	12 Jan 2022Luscient Diagnostics/ Vivera Pharmaceuticals/ EagleDx LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests	12 Jan 2022FDA
10 Jan 2022	10 Jan 2022Genrui SARS-COV-2 Rapid Antigen Self-Test	10 Jan 2022HPRA

Special Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below.

No record found

Note:

^* FDA = Food and Drug Administration, United States of America;
  MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
  Health Canada = Health Canada, Canada;
  TGA = Therapeutic Goods Administration, Australia;
  HPRA = Health Products Regulatory Authority, Ireland;
  HSA = Health Sciences Authority, Singapore