In-Vitro Diagnostic Medical Devices for COVID-19 NOT Listed Under MDACS (from 1 January 2022)

In-Vitro Diagnostic Medical Devices for COVID-19 NOT Listed Under MDACS (from 1 January 2022)

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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.

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Caption: Safety Alert Summary
Posting Date Description of Product Source of Information *
17 Oct 2024 CUE HEALTH INC Cue Health COVID-19 Test Cartridge FDA
17 Oct 2024 UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication FDA
14 Oct 2024 Luminex Molecular Diagnostics Inc 1) NxTAG Respiratory Pathogen Panel [REF: I051C0447]; 2) NxTAG Respiratory Pathogen Panel +SARS-CoV-2 [REF: I056C0468] FDA
30 Sep 2024 FENG 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 FDA
27 Sep 2024 Cepheid Xpert Xpress CoV-2/Flu/RSV plus TGA
14 May 2024 Do Not Use Cue Health's COVID-19 Tests Due to Risk of False Results: FDA Safety Communication FDA
13 May 2024 Becton Dickinson and Company BD SARS-CoV-2 Reagents for BD MAX Systems TGA
05 Apr 2024 Product Defect Correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - Potential for control line variability TGA
18 Mar 2024 Hangzhou Fanttest Biotech Co Ltd (Sponsored by Australia Health Products Central Pty Ltd) Fanttest COVID-19/lnfluenza A&B Antigen Test Kit TGA
22 Feb 2024 Sonictec 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] TGA
16 Feb 2024 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA [UDI-DI: 30014613339229; Lot number : 709083] FDA
25 Jan 2024 Hologic, Inc. PANTHER FUSION System REF 912101000 FDA
19 Jan 2024 PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 Rapid Antigen At-Home Test [REF: P0040; Lot: 22S0388-R01] FDA
23 Nov 2023 Cepheid 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] MHRA
21 Nov 2023 Abbott Rapid Diagnostics Pty Ltd ID NOW Instrument. An in vitro diagnostic medical device (IVD) [Part Number: NAT-000, NAT-000S; All serial numbers] TGA
17 Nov 2023 Pulse Oximeter Accuracy and Limitations: FDA Safety Communication FDA
25 Sep 2023 Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022 FDA
24 Jul 2023 Qiagen 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] FDA
07 Jul 2023 NeuMoDx Molecular Inc NeuMoDx SARS-CoV-2 Assay - IVD [Lot Number: 123909 Exp. Date: 08-Dec-2023] FDA
07 Jun 2023 QIAGEN 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] MHRA
06 Jun 2023 Becton Dickinson & Co. BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B [Catalog Number: 256088; Multiple lot numbers] FDA
06 Jun 2023 Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test [Reference Number: 691223] FDA
31 May 2023 ALLTEST Covid-19 Antigen Rapid Test (Oral Fluid) [ICOV-802H] and ALLTEST SARS-CoV-2 Antigen Rapid Test (Nasal Swab) [INCP-502H] DH
05 May 2023 SD Biosensor, Inc. Pilot COVID-19 At-Home Tests FDA
10 Feb 2023 Diasorin Molecular LLC Simplexa Covid-19 Direct [Model or Catalog Number: MOL4150; Lot or Serial Number: 13967N, 13968N, 15061N, 13330N, 13331N, 14016N, 13336N] Health Canada
10 Feb 2023 Diasorin Molecular LLC Simplexa Covid-19 & Flu A/B Direct [Model or Catalogue Number: MOL4250; Lot or Serial Number: 15058N, 15951N] Health Canada
30 Jan 2023 Universal 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] FDA
13 Dec 2022 Detect, Inc. Detect Covid-19 Test [Lot Numbers: HB264, HY263, HY264] FDA
09 Dec 2022 Dewei Medical Equipment Co. Dewei Medical Equipment Co. DNA/RNA Preservation Kits [Product Catalog Number: DW-80005-1B; Distribution Dates: May 2020 to January 2022] FDA
01 Dec 2022 GS 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 FDA
28 Oct 2022 LumiraDx 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] FDA
19 Oct 2022 American 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)] FDA
19 Oct 2022 LUMINOSTICS, 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] FDA
13 Oct 2022 Jiangsu Well Biotech Co., Ltd COVID-19 Ag Rapid Test Devices FDA
05 Oct 2022 Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883] MHRA
30 Sep 2022 Luminex 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)] Firm
14 Sep 2022 Abbott 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] FDA
25 Aug 2022 Assure Tech. Co. Ltd. Ecotest Covid-19 Antigen Rapid Test Device [model/catalogue: COV-S23002; Lot/serial: I2201505] Health Canada
24 Aug 2022 Luminex Corporation ARIES SARS-CoV-2 Assay [Lot: AB4042A] FDA
12 Aug 2022 At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication FDA
10 Aug 2022 Haimen 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] FDA
08 Aug 2022 Counterfeit COVID-19 antigen rapid test kits found in Ontario Health Canada
02 Aug 2022 North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits FDA
27 Jul 2022 LumiraDx 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)] FDA
20 Jul 2022 Ortho-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] FDA
06 Jun 2022 All Clean Natural Ltd. Surestrips Covid-19 Antigen Test [A03-50-422; 22010039, 22010040, 22010002, 21120019, 22010002, 22020004] Health Canada
06 Jun 2022 All Clean Natural Ltd. Surestrips Rapid Response Covid-19 Antigen Rapid Test Device [Model or Catalogue Number: COV-19C25; Lot or Serial Number: 21100017] Health Canada
18 May 2022 PROTERIXBIO 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] FDA
18 May 2022 USA Medical, LLC Diagnostic Kit SARS-cCo V Antigen Rapid Test [Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None] FDA
17 May 2022 Woodside Acquisitions Inc Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) FDA
11 May 2022 SML 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] FDA
10 May 2022 Mesa 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] FDA
29 Apr 2022 R-Biopharm Pty Ltd Control LQ COVID-19 IgG + IgM [K087M-6 Lot 06840] TGA
26 Apr 2022 Thermo Fisher Scientific Amplitude Platform with TaqPath COVID-19 HT Kit [Catalog #A50883] MHRA
06 Apr 2022 Seegen Allplex SARS-CoV-2 Variants II Assay [Product Code: RV10305X; All lots] MHRA
21 Mar 2022 Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication FDA
02 Mar 2022 ACON Laboratories, Inc. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) FDA
02 Mar 2022 Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Test FDA
25 Feb 2022 COVID-19 rapid antigen test kits and potential exposure to hazardous substances Health Canada
22 Feb 2022 Hangzhou 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] TGA
07 Feb 2022 E25Bio COVID-19 Direct Antigen Rapid Test FDA
07 Feb 2022 SD Biosensor, Inc STANDARD Q COVID-19 Ag Home Test FDA
31 Jan 2022 Empowered Diagnostics, LLC CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test [All lot codes] FDA
12 Jan 2022 Luscient Diagnostics/ Vivera Pharmaceuticals/ EagleDx LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests FDA
10 Jan 2022 Genrui SARS-COV-2 Rapid Antigen Self-Test HPRA

 

Special Alerts

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

No record found

Caption: Special Alerts
Posting Date Title

 

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