Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Alere Triage BNP PN 98000XR Intended to be used as Recalled by Alere San Diego, Inc. Due to Certain lots of the affected products may have...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alere San Diego, Inc. directly.
Affected Products
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).
Quantity: 30,083 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alere San Diego, Inc.
Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report