Z-0243-2022Class II

API 50 CH, Model 50300

Name: Z-0243-2022 API 50 CH, Model 50300
Creator: bioMerieux, Inc.
Published: 2021-09-30
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-09-30 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of API 50 CH, Model 50300 on 2021-09-30. FDA classified it as Class II and gives the reason as "There is potential to provide an incorrect organism identification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0243-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-30
Posted: 2021-11-17
Terminated: 2024-01-18
Recalling firm: bioMerieux, Inc.
Product: API 50 CH, Model 50300
Product code: JSC Culture Media, General Nutrient Broth
Reason for recall: There is potential to provide an incorrect organism identification.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 1382 kits
Distribution: Distribution in WI, NY, and SD
Product codes and lots: Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0243-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0243-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-17

Product code JSC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)