bioMerieux, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0847-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

VITEK 2 AST-N351 Test Kit

Product Classification:

Class II

Date Initiated: December 13, 2018

Date Posted: February 27, 2019

Recall Number: Z-0847-2019

Event ID: 81953

Reason for Recall:

False Positive ESBL Phenotype

Status: Terminated

Product Quantity: 30,292 cartons (20 cards per carton)

Code Information:

Ref: 421257 ALL LOTS

Distribution Pattern:

UK and Ireland

Voluntary or Mandated:

Voluntary: Firm initiated