| Date Initiated by Firm | March 12, 2003 |
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| Date Posted | May 14, 2003 |
|---|
| Recall Status1 |
Terminated 3 on February 03, 2005 |
| Recall Number | Z-0813-03 |
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| 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. |
| FEI Number |
1823260
|
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
|
| For Additional Information Contact |
800-428-4674 |
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Manufacturer Reason
for Recall | High frequency signals from other medical or communications equipment will result in a variable positive bias in test results. |
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FDA Determined
Cause 2 | Other |
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| 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
|
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