—#86536

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 The responsible firm name on the product labeling is Remel, 12076 Santa Fe Dr., Lenexa, KS 66215-3594

FDA product code: JXB — Kit, Identification, Yeast
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K943621
Affected lot / code info: ERIC (Electronic RapID Compendium) Version 1.0.77 -- Lot No. 0001096277

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

The firm issued an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated October 29, 2009. After completion of the firm's investigation and risk assessment, Remel decided to notify customers of this situation and quarantine any remaining units on hand. The notification provided the consignees with instructions for obtaining and downloading the software patch. A response form was included with the recall letter and the consignee was asked to complete the form and return it to Remel. The consignees should contact the Technical Services Department at 800-255-6730 (USA) or 913-888-0939 (International), if they have inquiries concerning this advisory.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide Distribution: USA, Europe and Canada

Timeline

Recall initiated: 2009-10-28
Posted by FDA: 2010-02-26
Terminated: 2010-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86536. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.