API 50 CH, Model 50300

There is potential to provide an incorrect organism identification.

Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021. Customers are asked to do the following: -Discontinue use of and discard any remaining inventory of lot 1008679230. -For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we are asking you to identify any possible incorrect identification test result due to a false positive reaction of test 34, analyze the related risks and to determine appropriate actions, if relevant. -Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. -Distribute this information to all appropriate personnel in the laboratory, retain a copy in your files. -Contact your local bioMrieux representative for product compensation. Consignees will perform destruction activities at their site.