Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access Thyroglobulin Antibody II (TgAbII) with the following details:

• Reference Number: A32898
• Lot Number: A) 831710; B) 831759; C) 832055; D) 832163
• Expiry: A) 31 May 2019; B) 31 Jul 2019; C) 30 Sep 2019; D) 31 Oct 2019

For use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600 and UniCel DxI 800, UniCel DxC 600i and the UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems

The manufacturer has determined through customer feedback and an internal investigation that the affected products may generate falsely decreased results in some patient samples when compared to previously released reagent lots. The failure was isolated to a specific lot of human thyroglobulin (Tg) antigen that was used to manufacture the affected TgAbII reagent lots.

According to the manufacturer, the affected lots of TgAbII reagent have been shown to generate repeatable (falsely decreased) results by up to 95% in some patient samples. Investigation indicates the potential for up to 10-15% of patient samples to be affected.

The affected users are advised to take the following actions:

• Discontinue use of the affected products and discard remaining reagent packs;
• At the discretion of their medical director, consider whether a review of Access Thyroglobulin Antibody results generated with the affected lot numbers is necessary.

The manufacturer is no longer distributing the affected lot numbers.

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

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

Posted on 13 February 2019