Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 coagulation or thromboembolic events including pulmonary embolism.

U.S. FDA — Device Enforcement · United States · 2012-05-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1932-2012
Date of alert: 2012-05-22
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Alere San Diego, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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 coagulation or thromboembolic events including pulmonary embolism.

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