Recalls / —

—#189710

Product

API 50 CH, Model 50300

FDA product code

JSC — Culture Media, General Nutrient Broth

Device class

Class 1

Medical specialty

Microbiology

Affected lot / code info

Model 50300, Lot 1008679230  UDI: (01)03573026087401 (17)220330 (10)1008679230

Why it was recalled

There is potential to provide an incorrect organism identification.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

Distribution in WI, NY, and SD

Timeline

Recall initiated

2021-09-30

Terminated

2024-01-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189710. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.