Date Initiated by Firm |
October 28, 2009 |
Date Posted |
February 26, 2010 |
Recall Status1 |
Terminated 3 on March 03, 2010 |
Recall Number |
Z-0870-2010 |
Recall Event ID |
53800 |
510(K)Number |
K943621
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Product Classification |
Kit, Identification, Yeast - Product Code JXB
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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
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Code Information |
ERIC (Electronic RapID Compendium) Version 1.0.77 -- Lot No. 0001096277 |
Recalling Firm/ Manufacturer |
Remel, Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact |
Debbie Wyatt 913-895-4075
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Manufacturer 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
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JXB and Original Applicant = INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
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