Alere Triage BNP Test for the Beckman Coulter Access Family of… — Class II medical device recall Z-1540-2014
Terminated recall by Alere San Diego, Inc., reported 2014-05-14, distributed nationwide. These lots may not recover within range when tested using certain commercially available controls.
| Recall number | Z-1540-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2014-03-20 |
| Classified | 2014-05-02 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2015-01-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CN, KR, MX, RU, SG, TW, ZA |
| Quantity | 12,592 kits |
| Lot numbers | 329599, 331265, K329599 |
| Model numbers | 98200 |
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 for recall
These lots may not recover within range when tested using certain commercially available controls.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1540-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.