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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS INTEGRA Creatinine Jaffe

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  Class 2 Device Recall COBAS INTEGRA Creatinine Jaffe see related information
Date Initiated by Firm February 13, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on March 20, 2003
Recall Number Z-0667-03
Recall Event ID 25569
510(K)Number K951595  
Product COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
Code Information lot 639106
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation.
FDA Determined
Cause 2		 Other
Action An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement.
Quantity in Commerce 1905
Distribution United States
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.
510(K) Database 510(K)s with Product Code = and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.
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