Triage Cardioprofiler and Profiler S.O.B. Panels

510(k) K080269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080269	Date6 Jun 2008Cleared	StatusActive

4 recalls · FDA

2 recalls, same reason
- Terminated Z-1928-2012 FDA Class I initiated 22 May 2012
- Terminated Z-1930-2012 FDA Class I initiated 22 May 2012 on shared 510(k) K080269
Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
2 recalls, same reason
- Terminated Z-1466-2012 FDA Not yet classified initiated 5 Mar 2012 on shared 510(k) K080269
- Terminated Z-1467-2012 FDA Not yet classified initiated 5 Mar 2012 on shared 510(k) K080269
Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)