Z-0870-2010

ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel...

Name: Z-0870-2010 ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel...
Creator: Remel, Inc
Published: 2009-10-28
License: https://open.fda.gov/license/

Remel Inc / initiated 2009-10-28 / Terminated / root cause: software

FDA source

Remel, Inc began a recall of ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative... on 2009-10-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0870-2010
Status: Terminated
Initiated: 2009-10-28
Posted: 2010-02-26
Terminated: 2010-03-03
Recalling firm: Remel Inc
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
Product code: JXB Kit, Identification, Yeast
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 143 units of software
Distribution: Worldwide Distribution: USA, Europe and Canada
Product codes and lots: ERIC (Electronic RapID Compendium) Version 1.0.77 -- Lot No. 0001096277

Product code JXB

K943621Class IRapid Yeast Plus SystemInnovative Diagnostic Systems, Inc. / cleared 1995-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)