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U.S. Department of Health and Human Services

Class 3 Device Recall Integra

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 Class 3 Device Recall Integrasee related information
Date Initiated by FirmFebruary 15, 2005
Date PostedMarch 23, 2005
Recall Status1 Terminated 3 on May 17, 2005
Recall NumberZ-0649-05
Recall Event ID 31056
510(K)NumberK003120 
Product Classification Assay, Glycosylated Hemoglobin - Product Code LCP
ProductRoche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
Code Information Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153, 650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
FDA Determined
Cause 2		Other
ActionRecall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
Quantity in Commerce347,000 cassettes
DistributionNationwide.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = LCP
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