Alere San Diego, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1540-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 20, 2014

Date Posted: May 14, 2014

Recall Number: Z-1540-2014

Event ID: 67910

Reason for Recall:

These lots may not recover within range when tested using certain commercially available controls.

Status: Terminated

Product Quantity: 12,592 kits

Code Information:

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

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated