Company:Remel, Inc.
Date of Enforcement Report 3/3//2010
Class:ll
PRODUCT
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. Recall # Z-0870-2010
REASON
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 RapID Yeast Plus panel, selecting “Display All Accessory Tests” indicated Growth at 37 o C for Candida albicans vs “No Growth” for Candida dubliniensis. The appropriate temperature range for resolving this overlap is 42-45 o C, at which C. albicans should exhibit growth but C. dubliniensis should not. The Instructions for Use for the RapID Yeast Plus System have recently been revised to address the biochemical similarities between these two species and indicates the correct methods to help distinguish between them. A software patch has been issued to modify the RapID Yeast Plus Database file. The patch is downloadable
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter dated October 29, 2009. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
143 units
DISTRIBUTION
Nationwide, Europe and Canada
