bioMerieux, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0243-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

API 50 CH, Model 50300

Product Classification:

Class II

Date Initiated: September 30, 2021

Date Posted: November 24, 2021

Recall Number: Z-0243-2022

Event ID: 88844

Reason for Recall:

There is potential to provide an incorrect organism identification.

Status: Terminated

Product Quantity: 1382 kits

Code Information:

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

Distribution Pattern:

Distribution in WI, NY, and SD

Voluntary or Mandated:

Voluntary: Firm initiated