Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Synchron Enzyme Validator [Product code: 441350; Lot number (Expiration date): M612600 (31 March 2018)].

The manufacturer has identified that a Supplemental Product information notification is missing from the affected lot.

According to the manufacturer, customers switching from Enzyme Validator Lots M510750 or older to Lot M612600 may observe differences in IFCC enzyme methods for GGT (REF 442650 and 476846) and AST- (REF 467845 and 467849).

• A positive bias up to 13 U/L for GGT was observed with Synchron Control Level 1.
• A negative bias up to 9% for AST- was observed with Synchron Control Level 3.
• Shifts in GGT and AST- were observed with other levels; however the recoveries were within the control insert ranges.

Customers switching from Enzyme Validator Lot M605630 to Lot M612600 are not impacted.

The affected users are advised to read the Supplemental Product Information and determine if control ranges need to be reassessed. Retrospective review of patient results is at the discretion of the Laboratory Director.

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 03 January 2018