Alere Triage Profiler SOB Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel 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 medical diagnostic device where decreased precision could lead to false positive or negative results, posing a risk of harm through misdiagnosis. 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 5,013 kits of the Alere Triage Profiler SOB Panel, Product Number 97300. The product is used to determine creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The recall covers lots distributed nationwide, specifically identified in Phase 1 and Phase 2 codes listed in the agency record.
The recall was initiated because certain lots of the affected products 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. The source text notes that these false results are unpredictable within lots and may not be detected by standard Quality Control testing.
Healthcare facilities and users of the affected lots should stop using the product and contact the recalling firm for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 5,013
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 (19)
- Phase 1: K50708B
- W50009B
- W50011B
- W50012B
- W50013B
- W50014B
- W50016VB
- W50021B
- W50026B
- W50028B
- W50030B
- W50771B
- W50772B
- W50773B
- W50774B
- W50778B
- and W50801B. Phase 2: W50015B
- W50029B
- and W50788B.
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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