Alere Triage¿ D-Dimer Test PN 98100 — Class II medical device recall Z-1727-2014
Terminated recall by Alere San Diego, Inc., reported 2014-06-18, distributed nationwide. Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884
| Recall number | Z-1727-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2014-05-02 |
| Classified | 2014-06-06 |
| Reported by FDA | 2014-06-18 |
| Terminated | 2015-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 373 kits |
| Lot numbers | W53884B |
Product
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Reason for recall
Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1727-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.