Alere Triage BNP Test Recalled for Potential Out-of-Range Results
Alere San Diego, Inc. is recalling specific lots of the Alere Triage BNP Test because they may not recover within range when tested with certain controls.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Alere San Diego, Inc. is recalling 12,592 kits of the Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200. The affected lot numbers are 329599 and 331265. These tests are intended to be used as an aid in the diagnosis of congestive heart failure, assessment of severity, and risk stratification for patients with acute coronary syndromes and heart failure.
The recall was initiated because these lots may not recover within range when tested using certain commercially available controls. This issue could affect the accuracy of the test results.
The affected products were distributed nationwide in the United States and internationally to Australia, Canada, China, the EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan, and the United Arab Emirates. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 12,592
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 (4)
- Model Number: 98200. Lot/Unit Codes: Lot #329599
- K329599 (Distributed OUS)
- 331265 and K331265 (Distributed OUS). Expiration date
- or Expected shelf life: 10/31/14 and 12/31/14
Distribution
Distributed nationwide across the United States.
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