Z-1727-2014Class II

Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay...

Name: Z-1727-2014 Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay...
Creator: Alere San Diego, Inc.
Published: 2014-05-02
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2014-05-02 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the... on 2014-05-02. FDA classified it as Class II and gives the reason as "Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either...". 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-1727-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-02
Posted: 2014-06-06
Terminated: 2015-02-27
Recalling firm: Alere San Diego, Inc.
Product: Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage D-Dimer test is intended for use 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: Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Alere sent an Urgent Medical Device Recall letter dated May 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to stop using all product from the affected lot, lot W53884B, and to discard any unused product. The customers were also instructed to complete and return the verification form indicating any credit or replacement product requested. They were also instructed to contact their primary consignees and advise them of the notice. Should you have any questions about the information contained in this notification, please call (877) 308-8287. and /or email:[email protected]
Quantity in commerce: 373 kits
Distribution: Nationwide Distribution only.
Product codes and lots: PN 98100, Lot W53884B.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1727-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-06

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)