Date Initiated by Firm | November 14, 2007 |
Date Posted | December 29, 2007 |
Recall Status1 |
Terminated 3 on September 22, 2009 |
Recall Number | Z-0379-2008 |
Recall Event ID |
45805 |
510(K)Number | K031880 |
Product Classification |
Analyte Calibrator - Product Code JJY
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Product | Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roche Diagnostics Corporation, Indianapolis, IN |
Code Information |
Lots No: 179021-01 and 179021-02; exp. 3/31/2008. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46250-0416
|
For Additional Information Contact | 800-428-2336 |
Manufacturer Reason for Recall | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. |
FDA Determined Cause 2 | Process design |
Action | Consignees were notified of this recall by an Urgent Medical Device Recall letter sent on 11/14/07. The letter instructed the users to immediately discontinue use of Ammonia/ Ethanol/CO2 Control N and Ammonia/Ethanol/CO2 Control A (with listed lots) for quality control assessment of the bicarbonate assay. They were informed that controls may still be used to assess ammonia and ethanol, but alternative controls must be used for assessment of the bicarbonate assay. Consignees are instructed to destroy products at their facility. Consignees were notified of the availability of replacement product via letter dated . |
Quantity in Commerce | 1,296 |
Distribution | Nationwide Distibution |
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 = JJY
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