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.
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 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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