API 50 CH, Model 50300
- Company
- Biomerieux, Inc.
- Recall Initiated
- September 30, 2021
- Terminated
- January 18, 2024
- Recall Number
- Z-0243-2022
- Quantity
- 1382 kits
- Firm Location
- Durham, NC
Reason for Recall
There is potential to provide an incorrect organism identification.
Distribution
Distribution in WI, NY, and SD
Lot / Code Info
Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
Root Cause
Material/Component Contamination
Action Taken
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.