Kit, Identification, Yeast
FDA adverse event reports and recall history for kit, identification, yeast (product code JXB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 169
- Deaths
- 0
- Injuries
- 1
- Malfunctions
- 168
Reports per year
Source: FDA adverse event reports by year received, 2003–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-01-04Open, ClassifiedStorage
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
- 2023-01-04Open, ClassifiedStorage
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
- 2017-05-22TerminatedPackaging
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).
- 2013-12-17TerminatedLabeling mix-ups
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 Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
- 2010-02-26TerminatedSoftware design
ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of the organisms addressed by the RapID Yeast Plus System is given in the RapID Yeast Plus Differential Chart. RapID" YEAST PLUS System, Catalog No. R8311007. 4 hour identification of yeast based on enzyme technology. Database includes over 40 taxa. Requires Inoculation Fluid, REF R8325106. CE, 20 Panels/Kit The responsible firm name on the product labeling is Remel, 12076 Santa Fe Dr., Lenexa, KS 66215-3594
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
- TerminatedEmployee error
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Monitor kit, identification, yeast automatically
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