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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm September 12, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on May 11, 2004
Recall Number Z-1293-03
Recall Event ID 27193
510(K)Number K974569  K962571  
Product Classification Test, Time, Prothrombin - Product Code GJS
Product CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
Code Information Catalog number 3116247 , Lots 591 and 619; Catalog # 1937642, Lot 600; and Catalog # 1937634, Lot 583. Extended to all lots with an expiration date of on or before March 1, 2005. 
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-4674
Manufacturer Reason
for Recall		 Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
FDA Determined
Cause 2		 Other
Action Urgent recall letters dated 9/12/03 were sent to customers of 2 lots on 9/12/03 instructing them to cease using the recalled lots and to inform the attending physician of any patients diagnosed using these lots. Distributors were asked to forward the letter to all customers who had received CoaguChek test strips or system care products. A copy of the recall notification was sent to the entire professional customer list reminding them to always inspect the product for seal integrity. The recall was extended to all lots via 9/26/03 press release. Recall letters were sent to all professional and home users on or about 10/1/03 advising them to inspect the package seal, to run each sample twice (with two test strips). Home users were asked to notify their physician of the problem.
Quantity in Commerce 363628
Distribution United States, Australia, Austria, Belgium, Chile, Czech Republic, Greece, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland and the United Kingdom.
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.
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