Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable 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 high-risk diagnostic device where inaccurate results could lead to misdiagnosis or improper treatment of heart failure, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Alere San Diego, Inc. is recalling 30,083 units of the Alere Triage BNP (PN 98000XR) medical device. This product is intended to be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. The recall covers specific lots distributed nationwide.
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 inaccurate results are unpredictable within lots and may not be detected by standard Quality Control testing.
The recall includes specific lot codes for Phase 1 and Phase 2. Phase 1 lots include K50671B, W49486B, W49487B, W49489B, W49498B, W49500B, W49873B, W49890B, W49895B, W49896B, W49934B, W49947B, W49948B, W49950B, W49962B, W49968B, W50257B, W50278B, W50279B, W50282B, W50287B, W50294B, and W50313B. Phase 2 lots include K50665B, W49855B, W49862B, W49865B, W49887B, W49892B, W49893B, W49894B, W49900B, W49933B, W49939B, W49953B, W49958B, W49960B, W49961B, W50252B, W50268B, W50273B, W50274B, W50290B, W50292B, W50295B, W50297B, W50298B, W50304B, W50355B, W50357B, and W50375B. Users should check their lot numbers against this list and contact the manufacturer for instructions.
The recalled product
- Product
- Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 30,083
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: K50671B
- W49486B
- W49487B
- W49489B
- W49498B
- W49500B
- W49873B
- W49890B
- W49895B
- W49896B
- W49934B
- W49947B
- W49948B
- W49950B
- W49962B
- W49968B
- W50257B
- W50278B
- W50279B
- W50282B
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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