Alere Triage Cardiac Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac 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 the hazard is inaccurate results (false positives/negatives) that could impact patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel (PN 97000HS). This medical device is used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin, and troponin I in EDTA anticoagulated whole blood or plasma specimens.
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. These errors are unpredictable within lots and may not be detected by Quality Control testing.
The affected products were distributed nationwide. Specific lot codes for Phase 1 and Phase 2 are listed in the official recall documentation. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 6,044
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: K50514B
- W49753B
- W49754B
- W49756B
- W49757B
- W49758B
- W49760B
- W49761B
- W49762B
- W49764B
- W49767B
- W49768B
- W49769B
- W49770B
- W50608B
- W50613B
- W50621B
- W50623B
- W50625B
- W50632B
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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