FDA Device recall Z-1932-2012
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulat…
- FDA Device
- Class I
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class I recall of Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulat… by Alere San Diego, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1932-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-22 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Phase 1: W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B. Phase 2: W50550B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1932-2012%22
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