Important Safety Alerts

Medical device manufacturer, BioMérieux Inc has issued a medical device safety alert concerning ZYM B reagent (Ref.:70493), API Listeria (Ref.: 10300) and API NH (Ref.: 10400).

BioMérieux identified a visual defect and activity issue on the ZYM B reagent. The investigations performed by BioMérieux's Quality Control Laboratory confirmed an activity issue on ZYM B reagent whatever the color of ZYM B ampule. This activity issue leads to a false negative result of some API biochemical tests using the ZYM B reagent.

BioMérieux explains that ZYM B reagent is used as an additional test for revealing the results of some miniaturized biochemical tests included in API 20 Strep (20600), API Coryne (20900), API Staph (20500) and API ZYM (25200). The ZYM B reagent is also included in API NH (10400) and API Listeria (10300).

The manufacturer provides the following recommendations to the affected users:

• For ZYM B (70493), API NH (10400) and API Listeria (10300) with ZYM B ampules having a visual defect (color not conform as described in the package insert), users are advised to destroy the kits and request product replacement.
• For ZYM B kits, API NH kits and API Listeria kits without visual defect, users are advised to either use them according to instructions given in the safety alert or discard them and request replacement kits.
• Users should discuss with their laboratory director to evaluate the impact and determine if retrospective analysis of results are required.

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

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

Posted on 18 November 2013