Medical device manufacturer, Trinity Biotech, has issued a medical device safety alert concerning its Premier Buffer A Reagent [Product Code (Lot Number): 01-03-0080 (6873, 6669)] and Premier Buffer B Reagent [Product Code (Lot Number):: 01-03-0081 (6374), 01-03-0096 (6859, 6639, 6506), 42664 (6528, 6633 and 6526)].

The manufacturer has received reports of difficulty in recovering controls (QC verification), using the above reagent lots, following system activation or standby mode. Upon review, the manufacturer has confirmed that the first two test results following system activation or standby mode, with these reagent lots, may result in a low bias, whether they are a control or patient sample.

The manufacturer is asking users of the above listed reagent lots for testing to review the following scenarios:

• If two controls were run directly after activation or standby and met acceptable criteria, there is no action required.
• If initial controls failed but were re-run and met acceptable criteria, there is no action required.
• If only patient samples were run directly after activation or standby, then a review of the first two (2) patient sample results is required.

Affected users should also take the following actions-

• Discontinue the use of the above reagent lots.
• Destroy any remaining product.
• Confirm end-users' laboratory practice of the use of two controls (QC verification) immediately following system standby and system activations.

According to the manufacturer, 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 28 February 2017