Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, has issued a medical device safety alert concerning all FTD CE-IVD kits, manufactured by Fast Track Diagnostics Luxembourg S.a.r.l. The affected catalogue numbers of FTD liquid (FTlyo) are identified as follow:-

• FTD-1.1, FTD-2 (FTlyo-2), FTD-2+.1 (FTlyo-2+.1), FTD-2P.3 (FTlyo-2P.3), FTD-3 (FTlyo-3s), FTD-7 (FTlyo-7), FTD-8.1, FTD-9.1, FTD-10.3, FTD-12.1, FTD-13 (FTlyo-13), FTD-14.1 (FTlyo-14.1), FTD-15.1, FTD-16, FTD-17, FTD-19, FTD-20.1 (FTlyo-20.1), FTD-21.1 (FTlyo-21.1), FTD-23 (FTlyo-23), FTD-24, FTD-27, FTD-28 (FTlyo-28), FTD-29.1, FTD-30, FTD-31.1, FTD-32,1, FTD-33.1 (FTlyo-33.1), FTD-34.1, (FTlyo-35), FTD-36, FTD-37, FTD-38, FTD-39 (FTlyo-39), FTD-40, FTD-42.1 (FTlyo-42.1), FTD-43 (FTlyo-43), FTD-44, FTD-45 (FTlyo-45), FTD-46, FTD-48.1 (FTlyo-48.1), FTD-50.1 (FTlyo-50.1), FTD-52.1, FTD-53.1, FTD-55.1, FTD-56.1 (FTlyo-56.1), FTD-57, FTD-60.4, FTD-62 , FTD-63.1, FTD-65.2 (FTlyo-65.2), FTD-66, FTD-67.1, FTD-69, FTD-71, FTD-73, FTD-74, FTD-75, FTD-77, FTD-78, FTD-82, FTD-84, (FTlyo-86), FTD-90

According to the manufacturer's internal investigation, it has revealed that, for the identified products, there is insufficient data to support the performance claims stated in the Instructions for Use. As a result, the European Conformity (CE) marking for the products are no longer valid and the product labelling is not compliant with the In Vitro Diagnostic Directive (IVDD). The risk to health related to the use of each product cannot be determined at this time.

For each CE IVD kit, the manufacturer is currently reviewing all available information, to ensure that it has considered all the facts before communicating details regarding the potential effects on patient safety.

Affected users are instructed to take the following actions:

• Discontinue use of any kits they may still have during the time of internal investigation.
• Quarantine the kits that they may have remaining in their stock.

The issue remains under investigation at the manufacturer. Additional information or updates will be provided as they become available.

For details, please refer to the following MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notice-16-to-20-december-2019

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 27 December 2019