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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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
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
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.