Alere Triage D-Dimer Test recallZ-1727-2014 · Alere San Diego, Inc. · initiated May 2, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alere San Diego, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-1727-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 2, 2014
- Posted by the FDA
- Jun 6, 2014
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 373 kits
- Product code
- GHH
- FDA submissions
- K042890
- Distribution
- Nationwide Distribution only.
Product description
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.
Code information (models, lots, serial numbers)
PN 98100, Lot W53884B.
Other devices under the same FDA submission
1 device cleared under K042890 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Triage 98100Quidel Cardiovascular Inc. · FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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