PlainRecalls
FDA Devices Moderate Class II Terminated

VITEK 2 AST-N351 Test Kit

Reported: February 27, 2019 Initiated: December 13, 2018 #Z-0847-2019

Product Description

VITEK 2 AST-N351 Test Kit

Reason for Recall

False Positive ESBL Phenotype

Details

Recalling Firm
bioMerieux, Inc.
Units Affected
30,292 cartons (20 cards per carton)
Distribution
UK and Ireland
Location
Durham, NC

Frequently Asked Questions

What product was recalled?
VITEK 2 AST-N351 Test Kit. Recalled by bioMerieux, Inc.. Units affected: 30,292 cartons (20 cards per carton).
Why was this product recalled?
False Positive ESBL Phenotype
Which agency issued this recall?
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0847-2019.