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U.S. Department of Health and Human Services

Class 2 Device Recall Coaguchek

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  Class 2 Device Recall Coaguchek see related information
Date Initiated by Firm February 28, 2007
Date Posted April 11, 2007
Recall Status1 Terminated 3 on June 13, 2007
Recall Number Z-0737-2007
Recall Event ID 37602
510(K)Number K974569  K962571  K930454  K994349  
Product Classification PLASMA, COAGULATION CONTROL , TEST STRIPS - Product Code GJS
Product CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
Code Information Lots 469A and 475A; exp. 6/30/2008.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-428-4674
Manufacturer Reason
for Recall		 The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
FDA Determined
Cause 2		 Other
Action All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
Quantity in Commerce 10
Distribution Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
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 = GJS and Original Applicant = BOEHRINGER MANNHEIM CORP.
510(K)s with Product Code = GJS and Original Applicant = ROCHE DIAGNOSTICS CORP.
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