Recall Z-0870-2010 ยท JXB Kit, Identification, Yeast
Remel, Inc
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 Ye
| Date | Feb 26, 2010 (initiated Oct 28, 2009) |
| Status | Terminated |
| 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 |
| 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 (Int |
| Quantity | 143 units of software |
| Distribution | Worldwide Distribution: USA, Europe and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943621 | RAPID YEAST PLUS SYSTEM Innovative Diagnostic Systems, Inc., Jan 27, 1995 |