Date Initiated by Firm |
March 12, 2003 |
Date Posted |
May 14, 2003 |
Recall Status1 |
Terminated 3 on February 03, 2005 |
Recall Number |
Z-0814-03 |
Recall Event ID |
25574 |
510(K)Number |
K860719
|
Product Classification |
System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
|
Product |
CoaguChek Plus meter; catalog # 475729 and 12816001. |
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 |
472 |
Distribution |
United States |
Total Product Life Cycle |
TPLC Device Report
|
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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 = BIOTRACK, INC.
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