Recall Z-0243-2022 ยท JSC Culture Media, General Nutrient Broth
bioMerieux, Inc.
API 50 CH, Model 50300
| Date | Sep 30, 2021 |
| Status | Terminated |
| Reason | There is potential to provide an incorrect organism identification. |
| Root cause | Material/Component Contamination |
| Action | 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 |
| Quantity | 1382 kits |
| Distribution | Distribution in WI, NY, and SD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.