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U.S. Department of Health and Human Services

Class 3 Device Recall MIRA

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  Class 3 Device Recall MIRA see related information
Date Initiated by Firm February 15, 2005
Date Posted March 23, 2005
Recall Status1 Terminated 3 on May 17, 2005
Recall Number Z-0650-05
Recall Event ID 31056
510(K)Number K952337  
Product Classification Assay, Glycosylated Hemoglobin - Product Code LCP
Product Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
Code Information Lots 646340, 650984, 651640 and 653292.
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
Action Recall 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 Commerce 1800 kits.
Distribution Nationwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LCP and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.
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