Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. |
|---|---|
| Recall Number | Z-1932-2012 |
| Classification | Class I |
| Code Info | Phase 1: W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B. Phase 2: W50550B |
| Product Distributed Qty | 1,972 kits |
| Reason For Recall | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing. |
Event Detail
| Event Id | 61927 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Alere San Diego, Inc. |
| City | San Diego |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
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