Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena...
FDA Device Recall #Z-2761-2019 — Class II — December 7, 2017
Recall Summary
| Recall Number | Z-2761-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 7, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Helena Laboratories, Corp. |
| Location | Beaumont, TX |
| Product Type | Devices |
| Quantity | 21 kits |
Product Description
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for Recall
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Distribution Pattern
Distribution was made to Germany and Australia. There was no U.S. distribution.
Lot / Code Information
Lot number 2-17-5722, Exp. 2018-09-30
Other Recalls from Helena Laboratories, Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1975-2023 | Class II | Serrated Blade Applicator Kit (12 Sample), REF:... | May 2, 2023 |
| Z-1244-2022 | Class II | V8 Immunodisplacement Kit REF 1803 | Apr 6, 2022 |
| Z-1108-2021 | Class II | Cascade Abrazo aPTT Test Card - Product Usage: ... | Jan 5, 2021 |
| Z-0635-2021 | Class II | K-ACT Actalyke Clotting Test Tubes that are use... | Nov 9, 2020 |
| Z-1950-2019 | Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/... | Aug 8, 2018 |
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.