Z-1932-2012Class I

Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having...

Name: Z-1932-2012 Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having...
Creator: Alere San Diego, Inc.
Published: 2012-05-22
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2012-05-22 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or... on 2012-05-22. FDA classified it as Class I and gives the reason as "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...". 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-1932-2012
Classification: Class I
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-07-06
Terminated: 2013-10-18
Recalling firm: Alere San Diego, Inc.
Product: Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Product code: GHH Fibrin Split Products
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Phase 1 of the recall included a recall communication being initiated on May 22, 2012 with Alere forwarding a recall letter to all their customers who purchased the Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use of the affected product, and to complete and fax the enclosed verification form within 10 days. Phase 2 of the recall included a recall communication letter being forwarded to customers on 6/11/12. The second letter included additional lots of Triage products that go beyond the lots included in an earlier recall notification letter. The letter informed the customers that the additional lots have significantly decreased precision relative to the package insert which could result in an increased frequency of false positive or false negative results. A third letter dated June 12, 2012 included 3 more lots for the Triage Cardio Profiler Panel PN 97100CP and Alere Triage Profiler SOB Panel PN 97300. The letter informed the customers that the additional lots have an increased frequency of Troponin I results >0.05 ng/mL for samples which are found to be below 0.05 ng/mL upon additional testing. Customers with questions about the information contained in the notifications, were instructed to contact Alere San Diego at (877) 308-8287 or at 9975 Summers Ridge Road, San Diego, CA 92121.
Quantity in commerce: 1,972 kits
Distribution: Nationwide Distribution
Product codes and lots: Phase 1: W50069B, W50070B, W50071B, W50541B, W50551B, W50552B, and W50556B. Phase 2: W50550B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1932-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1929-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1930-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1931-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06
Z-1932-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code GHH

K042890Class IITriage D-Dimer Test, Model 98100Biosite Incorporated / cleared 2004-11-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)