Alere Triage CardioProfiler Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause 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 risk-of-harm product (medical diagnostic device) where injury has not yet been reported, fitting the 'High' severity criteria for unpredictable false results.
Plain-English summary
Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel (PN 97100CP). The product is used for the quantitative determination of creatine kinase MB, myoglobin, troponin I, and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. The recall covers lots distributed nationwide.
The recall is being conducted 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. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
The affected lots are identified by specific codes listed in the recall notice. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
- Manufacturer
- Alere San Diego, Inc.
- Affected units
- 16,962
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 (20)
- Phase 1: W49604B
- W49606B
- W49607B
- W49611B
- W49612B
- W49613B
- W49614B
- W49615B
- W49616B
- W49617B
- W49620B
- W49622B
- W49623B
- W49624B
- W49625B
- W49627B
- W49628B
- W49629B
- W49630B
- W49631B
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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