Alere Triage D-Dimer Test Recalled for Incorrect Manufacturing
Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test (Lot W53884B) because they may generate error codes or incorrect results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may generate incorrect diagnostic results for serious conditions, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test, Product Number 98100, Lot W53884B. The affected devices were distributed nationwide. The Alere Triage D-Dimer Test is a fluorescence immunoassay used with Alere Triage Meters to determine cross-linked fibrin degradation products in whole blood and plasma specimens. It is intended as an aid in assessing patients suspected of having disseminated intravascular coagulation or thromboembolic events, including pulmonary embolism.
The recall was initiated because a limited number of these devices were incorrectly manufactured. As a result, when testing patient samples, the affected devices may generate an error code, such as an E4 error, or they may generate an incorrect result. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare facilities and users should stop using the affected lots immediately and contact Alere San Diego, Inc. for instructions on returning the devices or obtaining replacements.
The recalled product
- 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…
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 373
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- PN 98100
- Lot W53884B.
Distribution
Distributed nationwide across the United States.
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