FDA Device recall Z-1928-2014
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is int…
- FDA Device
- Class III
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class III recall of Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is int… by Alere San Diego, citing alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1928-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-30 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
Reason
Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
Identifiers
| code_info | Lot #328163 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.