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).
Reported: July 18, 2012 Initiated: May 22, 2012 #Z-1931-2012
Product Description
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).
Reason for Recall
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.
Details
- Recalling Firm
- Alere San Diego, Inc.
- Units Affected
- 30,083 kits
- Distribution
- Nationwide Distribution
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Alere San Diego, Inc.. Units affected: 30,083 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Critical. Recall number: Z-1931-2012.
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