Z-0243-2022 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
November 24, 2021
Initiation Date
September 30, 2021
Termination Date
January 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1382 kits

Product Description

API 50 CH, Model 50300

Reason for Recall

There is potential to provide an incorrect organism identification.

Distribution Pattern

Distribution in WI, NY, and SD

Code Information

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