Recall Z-1540-2014— Alere San Diego, Inc.
Class II · Terminated
Class II FDA medical device recall by Alere San Diego, Inc., initiated 2014-03-20, terminated 2015-01-23. It names one FDA 510(k) clearance: K052789. Product: 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.. Reason: These lots may not recover within range when tested using certain commercially available controls..
- Recalling firm
- Alere San Diego, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-20
- Terminated
- 2015-01-23
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
These lots may not recover within range when tested using certain commercially available controls.
Data sourced from openFDA. This site is unofficial and independent of the FDA.