Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its API 50 CH [Reference: 50300; Lot number: 1008603700].
According the manufacturer, it was confirmed during an internal investigation that test 19 of API 50 CH lot# 1008603700 contains a mix of sorbitol (SOR) and 5-ketogluconic acid (5KG) instead of sorbitol only. Whereas all the other tests of the gallery were confirmed to be conform. Retain samples of lot 1008603700 were tested using bacterial strains selected among the more impacted species by a test SOR containing 5KG and for some strains a false positive reaction on test 19 was obtained. Based on the investigation results, there is a potential to obtain doubtful profile and, in the worst-case scenario, incorrect identification test result due to the false positive reaction on test 19.
Affected users should discontinue using and discard any remaining inventory of API 50 CH Lot 1008603700. For tests previously performed using API 50 CH Ref. 50300 lot# 1008603700, the manufacturer is instructing affected users to identify any possible incorrect identification test result due to a false positive reaction of test 19, analyze the related risks and to determine appropriate actions, if relevant.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Aug 2021