Biomerieux Inc ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Brand
Biomerieux Inc
Lot Codes / Batch Numbers
UDI/DI 03573026376567, Batch Numbers: 1009209480
Products Sold
UDI/DI 03573026376567, Batch Numbers: 1009209480
Biomerieux Inc is recalling ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 due to As the temperature and time out of range was exceeded, product performances cannot be guaranteed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026