Z-1467-2012

Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial...

Name: Z-1467-2012 Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial...
Creator: Alere San Diego
Published: 2012-03-05
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-03-05 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego began a recall of Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and... on 2012-03-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1467-2012
Status: Terminated
Initiated: 2012-03-05
Posted: 2012-04-26
Terminated: 2012-12-04
Recalling firm: Alere San Diego, Inc.
Product: Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall communication was initiated on 3/15/12 with Alere San Diego, Inc. forwarding a "Urgent Medical Device Recall" letter to all their customers who purchased the Alere Triage CardioProfiler Panel PN 97100CP, Lot W49569 and Alere Triage Profiler SOB Panel PN 97300, Lot W48990. The letter informed the customers about the problems identified and the actions to be taken. Customers with any questions about the information contained in this notification should contact Alere San Diego, Inc. at (877) 308-8287.
Quantity in commerce: 1,316 kits
Distribution: Worldwide Distribution, including Nationwide (US) and the countries of Brazil, China, India and Kuwait.
Product codes and lots: Lot Code: W48990 Phase 2 (June 12, 2012): Lot#W50019, W50027

Product code MMI

K080269Class IITriage Cardioprofiler and Profiler S.o.b. PanelsBiosite Incorporated / cleared 2008-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)