Kit, Identification, Yeast
Microbiology · 21 CFR 866.2660
Recent MDR events
169 adverse event reports on file
- BD PHOENIX¿ YEAST IDJul 22, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-01768
- BD PHOENIX¿ YEAST IDJun 30, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00750
- BD PHOENIX¿ YEAST IDJun 30, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00749
- BD PHOENIX¿ YEAST IDJun 26, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00600
- BD PHOENIX¿ YEAST IDJun 26, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00601
- BD PHOENIX¿ YEAST IDJan 29, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00016
- BD PHOENIX¿ YEAST IDApr 26, 2024MalfunctionBecton Dickinson & Co. (sparks)1119779-2024-00317
- BD PHOENIX¿ YEAST IDJan 22, 2024MalfunctionBecton, Dickinson & Co. (sparks)1119779-2024-00036
- BD PHOENIX¿ YEAST IDJun 27, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00721
- BD PHOENIX¿ YEAST IDMay 16, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00564
Event type breakdown
Recalls
6 recall events for this product code
- Biomerieux IncOpen, ClassifiedJan 4, 2023
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0785-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0789-2023 · View FDA record ↗ - Biomerieux IncTerminatedMay 22, 2017
VITEK 2 Yeast identification card (YST), IVD, REF 21343, 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-2343-2017 · View FDA record ↗ - Remel IncTerminatedDec 17, 2013
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reag
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Z-0530-2014 · View FDA record ↗ - Remel, IncTerminatedFeb 26, 2010
ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micrometho
There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and Candida dubliniensis. When using the
Z-0870-2010 · View FDA record ↗ - Biomerieux IncTerminatedUnknown
API ID 32 C Strips, Reference 32200, Rx Only, IVD
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Z-0525-2022 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
Ups Supply Chain Solutions, Inc.
Mira Loma, CA, US
Beckman Coulter, Inc.
West Sacramento, CA, US
Ups Supply Chain Solutions, Inc.
Pedricktown, NJ, US
Remel, Inc.
LENEXA, KS, US
Synergy Health Sterilisation Uk Ltd
Swindon Wiltshire, GB
Becton, Dickinson & Co.
SPARKS, MD, US
Biomerieux, Inc.
HAZELWOOD, MO, US
Biomerieux Sa
LA BALME LES GROTTES Isere, FR
Remel Europe Ltd
DARTFORD, KENT, GB
Medical Wire And Equipment Co. Ltd.
CORSHAM, WILTSHIRE, GB
Biomerieux France
CRAPONNE Rhone, FR
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
510(k) clearances
16 clearances for this product code
- Advandx, Inc.Sep 12, 2008
K080719 · YEAST TRAFFIC LIGHT PNA FISH
- Advandx, Inc.Oct 25, 2006
K062461 · C. ALBICANS PNA FISH
- Diagnostic Markers, Inc.Feb 10, 2000
K993554 · YEASTEST
- Innovative Diagnostic Systems, Inc.Jan 27, 1995
K943621 · RAPID YEAST PLUS SYSTEM
- Remel Co.Feb 25, 1994
K935124 · BACTICARD CANDIDA
- Medical Wire & Equipment Co.Jul 31, 1990
K900112 · MICRORING YT
- Vitek Systems, Inc.Jun 16, 1988
K881925 · VITEK YEAST BIOCHEMICAL CARD
- American Micro ScanMay 13, 1986
K860575 · YEAST IDENTIFICATION PANEL