Device product

VITEK 2 AST-N351 Test Kit

Z-0847-2019

December 13, 2018

Class II

Product summary

Firm: bioMerieux, Inc.
Event: Event 81953
Status: Terminated
Classification: Class II
Quantity: 30,292 cartons (20 cards per carton)
Official record key: device-enforcement:Z-0847-2019

Official wording

Reason: False Positive ESBL Phenotype

Code information: Ref: 421257 ALL LOTS

Distribution pattern: UK and Ireland

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

False Positive ESBL Phenotype