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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false…"
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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