CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report
Alere Triage¿ D-Dimer Test PN recalled by Alere San Diego
Alere San Diego is recalling Alere Triage¿ D-Dimer Test PN 98100, distributed nationwide in the US. The recall was initiated on 2 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1727-2014
- FDA event ID
- 68230
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2014
- FDA classified
- 6 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Heart & Vascular Devices
Timeline
| 2 May 2014 | Recall initiated by company | |
| 6 Jun 2014 | Classified by FDA | +35 days |
| 18 Jun 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution only.
Questions about this recall
Is Alere Triage¿ D-Dimer Test PN 98100 recalled?
Yes. Alere San Diego recalled Alere Triage¿ D-Dimer Test PN 98100 on 2 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1727-2014.
Why was it recalled?
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.
Which lots are affected?
PN 98100, Lot W53884B.
Where was it sold?
Nationwide Distribution only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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