Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access Free T3 Reagent Kit [Reference number: A13422] for use with the Access Family of Immunoassay Systems.

The manufacturer has determined through customer feedback and internal testing that the affected lots of Access Free T3 Reagent demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots.

According to the manufacturer, patient sample results will shift upward by approximately 10-14% across the reference interval when compared to the results generated with reagent lots manufactured prior to the June 2015 design change. Additional assay performance characteristics are not affected. Due to matrix differences, QC values may not demonstrate a shift.

Customers are advised to take the following actions:

• Discontinue using the affected Access Free T3 lots until their laboratory verifies that their current Access Free T3 reference interval(s) is appropriate; or adjusts or establishes new reference interval(s);
• To verify, adjust or establish new Access Free T3 reference interval(s);
• Resume using the affected Access Free T3 lots and all future lots once their laboratory has completed the reference interval evaluation; and
• At the discretion of their Laboratory Director, notify clinicians that it is possible the Access Free T3 sample results previously reported by their laboratory were affected by this issue.

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 16 June 2016