Medical device manufacturer, Trinity Biotech, has issued a medical device safety alert concerning its GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH). The details of the affected device are as follows:-

• Assay Product Code: 345A
  • Lot Number: F117009 (Expiry Date: 04-Apr-18)
  • Date of Manufacture: 04 APR 16
• Assay Product Code: 345B
  • Lot Number: F229031 (Expiry Date: 18-Jul-18)
  • Date of Manufacture: 18 JUL 16

The manufacturer has identified a potential for misdiagnosis with lots F117009 and F229031. A recent investigation has identified that these two lots display a level of accuracy variation outside the historical QC product release process control charts for normal range controls, despite falling within the QC acceptance specification. Kits from these two lots must be destroyed.

Investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring.

Affected users and end-users are asked to comply with the following actions with immediate effect:

• Discontinue the use of the lots F117009 and F229031.
• Destroy any remaining product.
• In line with their laboratory's internal procedures, consider the need to review results previously generated using these lots.
• Notify all end-users of this notification.

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 23 December 2016