FDA Medical Device Recalls (openFDA)
Alere San Diego, Inc.: 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.
- Recall number
- Z-1540-2014
- Recalling firm
- Alere San Diego, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-03-20
- Posted
- 2014-05-02
- Terminated
- 2015-01-23
- Reason
- These lots may not recover within range when tested using certain commercially available controls.
- Root cause
- Under Investigation by firm
- Action
- Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Reagent Pack Lots 329599 or 331265, they can receive the Alere Triage BNP QC Controls PN 98201 by requesting them on the Verification Form. "Customers were instructed to share this information with their laboratory staff, including their laboratorys medical director and retain this notification as part of their laboratory Quality System documentation. For questions regarding this recall call 858-805-2000, ext 3015. " If they have forwarded the product listed above to another laboratory, please provide a copy of this letter to them. " Complete and FAX the enclosed Verification Form within 10 days to confirm your receipt of this notice. Only one Verification Form is required per facility. Customers with questions were instructed to call 877-308-8287 or email Triage.Support@alere.com.
- Quantity
- 12,592 kits
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K052789"]
- PMA numbers
- not on file
- Product code
- NBC
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28