bioMerieux, Inc. API 50 CH, Model 50300 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
API 50 CH, Model 50300
Brand
bioMerieux, Inc.
Lot Codes / Batch Numbers
Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
Products Sold
Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
bioMerieux, Inc. is recalling API 50 CH, Model 50300 due to There is potential to provide an incorrect organism identification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is potential to provide an incorrect organism identification.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
IN, NY, SD, WI
Page updated: Jan 10, 2026