Alere Triage D-dimer Kits Recalled for Decreased Precision
Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.
What this means for you
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 high-risk medical device where decreased precision can lead to false positive or negative results for serious conditions like pulmonary embolism. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Alere San Diego, Inc. is recalling 1,972 Triage D-dimer kits (PN 98100) distributed nationwide. The product is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events, including pulmonary embolism.
The recall is due to a potential defect where certain lots may have significantly decreased precision relative to the package insert. This issue could result in an increased frequency of false positive or false negative results. These errors are unpredictable within lots and may not be detected by standard Quality Control testing.
The affected lots are identified by the following codes: Phase 1 includes W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B; Phase 2 includes W50550B. Healthcare providers and facilities should check their inventory for these specific lot codes and stop using the affected kits.
The recalled product
- 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.
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 1,972
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 (7)
- Phase 1: W50069B
- W50070B
- W50071B
- W50541B
- W50551B
- W50552B
- and W50556B. Phase 2: W50550B
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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