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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 October 18, 2006
Date Posted November 30, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0227-2007
Recall Event ID 36587
510(K)Number K974569  K962571  K930454  K994349  
Product Classification PT Test Strips (blood clotting time) Anticoagulant - Product Code GJS
Product CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].
Code Information All lots.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-820-0995
Manufacturer Reason
for Recall		 Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
FDA Determined
Cause 2		 Other
Action A press release was issued by the firm on 10/19/06. The recall letter dated 10/19/06 sent to distributors who sell to home users instructs them to notify their home users and to discard any of product 3116239 in stock. The recall letter dated 10/19/06 to to home users, instructs them to discontinue use of, and to discard, their test strips and to contact their health care professional. The device correction letter dated 10/19/06 to distributors to professional users instructs them to notify customers and provides instructions for duplicate testing in laboratories. The device correction letter dated 10/19/06 to health care professionals asks that they follow-up with their home users to ensure they follow the instructions to cease home use and provides instructions for dupicate testing in laboratories.
Quantity in Commerce Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S.
Distribution Worldwide
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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