Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluoresce...
FDA Device Recall #Z-1727-2014 — Class II — May 2, 2014
Recall Summary
| Recall Number | Z-1727-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 2, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alere San Diego, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 373 kits |
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.
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.
Distribution Pattern
Nationwide Distribution only.
Lot / Code Information
PN 98100, Lot W53884B.
Other Recalls from Alere San Diego, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1702-2024 | Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP65... | Mar 1, 2024 |
| Z-1508-2022 | Class II | The Cholestech LDX¿ System combines enzymatic m... | Jun 24, 2022 |
| Z-2475-2019 | Class II | Alere Cholestech LDX Analyzer, model # 14-874 c... | Feb 15, 2019 |
| Z-0418-2018 | Class II | Triage Drugs of Abuse Plus TCA 25 Test Kit, Mod... | Nov 14, 2017 |
| Z-0588-2017 | Class II | Alere Triage Total 5 Control Level 1, Model No.... | Oct 12, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.