Device 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).
Z-1931-2012
Product summary
- Event
- Event 61927
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30,083 kits
- Official record key
device-enforcement:Z-1931-2012
Official wording
Reason: 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 negative results are unpredictable within lots and may not be detected by Quality Control testing.
Code information: Phase 1: 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: 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.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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 negative results are unpredictable within lots and may not be detected by Quality Control testing.