Recalls / —

—#197055

Product

API 20 E 25 STRIPS, CATALOG 20100

FDA product code

JSS — Kit, Identification, Enterobacteriaceae

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

UDI/DI 03573026047818, Batch Number 1009226560

Why it was recalled

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Root cause (FDA determination)

Storage

Action the firm took

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.

Recalling firm

Firm

Biomerieux Inc

Address

595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2022-11-09

Posted by FDA

2023-01-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.