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U.S. Department of Health and Human Services

Class 2 Device Recall CoaguChek Pro DM System

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  Class 2 Device Recall CoaguChek Pro DM System see related information
Date Initiated by Firm March 12, 2003
Date Posted May 14, 2003
Recall Status1 Terminated 3 on February 03, 2005
Recall Number Z-0813-03
Recall Event ID 25574
510(K)Number K983892  
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product CoaguChek Pro DM meter; catalog # 1894048 and 1893211.
Code Information All units.
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
For Additional Information Contact
800-428-4674
Manufacturer Reason
for Recall
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
FDA Determined
Cause 2
Other
Action Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.
Quantity in Commerce 1322
Distribution United States
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 = JPA and Original Applicant = ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
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