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U.S. Department of Health and Human Services

Class 2 Device Recall Roche

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  Class 2 Device Recall Roche see related information
Date Initiated by Firm June 07, 2006
Date Posted June 27, 2006
Recall Status1 Terminated 3 on April 23, 2008
Recall Number Z-1176-06
Recall Event ID 35493
510(K)Number K041009  
Product Classification Cresolphthalein Complexone, Calcium - Product Code CIC
Product Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
Code Information Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
FDA Determined
Cause 2		 Other
Action Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.
Quantity in Commerce 933 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 = CIC and Original Applicant = HEMAGEN DIAGNOSTICS, INC.
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