Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LAB...
FDA Device Recall #Z-0594-2019 — Class II — April 20, 2016
Recall Summary
| Recall Number | Z-0594-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 20, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Helena Laboratories, Inc. |
| Location | Beaumont, TX |
| Product Type | Devices |
| Quantity | 12 Kits |
Product Description
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
Reason for Recall
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Distribution Pattern
US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Lot / Code Information
Lot Codes: 1-15-5701 Model/Catalog Number: 5701
Other Recalls from Helena Laboratories, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0106-2019 | Class II | "Free and Total Protein S ELISA Kit" Cat. No. 5... | Apr 4, 2017 |
| Z-0561-2019 | Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN V... | Feb 24, 2017 |
| Z-0529-2019 | Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit:... | Nov 7, 2016 |
| Z-2434-2019 | Class II | Titan Gel Serum Protein Control: SPE Control Ca... | Oct 14, 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.