FDAFDA · Food and drugs·Recall number Z-1540-2014
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes, and for the risk stratification of patients with heart failure.
Published May 14, 2014 · Recall initiated: March 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
These lots may not recover within range when tested using certain commercially available controls.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alere San Diego, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
- Lot
- Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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