Z-0847-2019 Class II Terminated
FDA device recall Z-0847-2019 was initiated by bioMerieux, Inc. on Dec 13, 2018 and is designated Class II. Reason for recall: False Positive ESBL Phenotype The recall status is terminated (terminated Aug 16, 2021). Affected quantity: 30,292 cartons (20 cards per carton).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Dec 13, 2018
- Termination Date
- Aug 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,292 cartons (20 cards per carton)
Product Description
VITEK 2 AST-N351 Test Kit
Reason for Recall
False Positive ESBL Phenotype
Distribution Pattern
UK and Ireland
Code Information
Ref: 421257 ALL LOTS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0847-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026