Kit, Anaerobic Identification
Microbiology · 21 CFR 866.2660
Recent MDR events
64 adverse event reports on file
- API 20 A 25STRIPS+25MEDIAOct 27, 2021MalfunctionBiomérieux, Sa9615754-2021-00276
- API® 20 A 25STRIPS+25MEDIAMay 24, 2021MalfunctionBiomérieux, Sa9615754-2021-00168
- API 20 A 25STRIPS+25MEDIAOct 14, 2020MalfunctionBiomérieux, Sa9615754-2020-00159
- VITEK® 2 ANC TEST KITMay 17, 2018MalfunctionBiomerieux Inc.1950204-2018-00188
- VITEK® 2 ANC TEST KITMay 16, 2018MalfunctionBiomerieux Inc.1950204-2018-00193
- VITEK® 2 ANC TEST KITMay 9, 2018MalfunctionBiomerieux Inc.1950204-2018-00181
- VITEK® 2 ANC TEST KITMay 9, 2018MalfunctionBiomerieux Inc.1950204-2018-00182
- VITEK® 2 ANC TEST KITApr 25, 2018MalfunctionBiomerieux Inc.1950204-2018-00162
- VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KITMar 27, 2018MalfunctionBiomérieux, Inc.1950204-2018-00119
- VITEK® 2 ANAEROBIC AND CORYNEBACTERIA (ANC) IDENTIFICATION (ID) TEST KITFeb 23, 2018MalfunctionBiomérieux, Inc.1950204-2018-00085
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Biomerieux IncTerminatedMay 22, 2017
VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Z-2346-2017 · View FDA record ↗ - BioMerieux SATerminatedUnknown
The VITEK 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK 2 Systems for the automated identification of most clinica
A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Z-2166-2018 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
Beckman Coulter, Inc.
West Sacramento, CA, US
Biomerieux Sa
LA BALME LES GROTTES Isere, FR
Ups Supply Chain Solutions, Inc.
Mira Loma, CA, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Biomerieux, Inc.
HAZELWOOD, MO, US
Ups Supply Chain Solutions, Inc.
Pedricktown, NJ, US
Remel, Inc.
LENEXA, KS, US
Remel Europe Ltd
DARTFORD, KENT, GB
510(k) clearances
18 clearances for this product code
- Microbiologics, Inc.May 11, 1995
K945488 · LYFO(TM) DIFFERENTIAL DISK
- Microbiologics, Inc.May 11, 1995
K945489 · LYFO(TM) DIFFERENTIAL DISK
- Microbiologics, Inc.May 11, 1995
K945487 · LYFO(TM) DIFFERENTIAL DISK
- Becton Dickinson Microbiology SystemsMar 7, 1995
K944528 · BBLCRYSTAL ANAEROBE ID SYSTEM
- Vitek Systems, Inc.Apr 3, 1991
K910666 · VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
- Vitek Systems, Inc.May 11, 1990
K900996 · VITEK ANAEROBE IDENTIFICATION CARD
- American Biomedical Products, Inc.Oct 6, 1988
K881380 · B. FRAGTEX
- Innovative Diagnostic Systems, Inc.Aug 12, 1988
K882960 · IDS RAPID ANA SYSTEM