PlainRecalls
FDA Devices Moderate Class II Terminated

API 50 CH, Model 50300

Reported: November 24, 2021 Initiated: September 30, 2021 #Z-0243-2022

Product Description

API 50 CH, Model 50300

Reason for Recall

There is potential to provide an incorrect organism identification.

Details

Recalling Firm
bioMerieux, Inc.
Units Affected
1382 kits
Distribution
Distribution in WI, NY, and SD
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
API 50 CH, Model 50300. Recalled by bioMerieux, Inc.. Units affected: 1382 kits.
Why was this product recalled?
There is potential to provide an incorrect organism identification.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 24, 2021. Severity: Moderate. Recall number: Z-0243-2022.