API JAMES 2AMP, CATALOG 70542
- Company
- Biomerieux Inc
- Recall Initiated
- November 9, 2022
- Posted
- January 4, 2023
- Recall Number
- Z-0810-2023
- Quantity
- 1 unit
- Firm Location
- Hazelwood, MO
Reason for Recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 03573026099893, Batch Numbers: 1009360510
Root Cause
Storage
Action Taken
Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments. 3. Stop using and scrap any remaining impacted products in your inventory. a. Request product replacement or credit for the destroyed product. b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement Form. 4. Please store this letter with your bioMrieux documentation. 5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible." The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022.