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-0561-2019 — Class II — February 24, 2017

Recall Summary

Recall Number Z-0561-2019
Classification Class II — Moderate risk
Date Initiated February 24, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Helena Laboratories, Inc.
Location Beaumont, TX
Product Type Devices
Quantity 27 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

Reason for Recall

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Distribution Pattern

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

Lot / Code Information

Lot Codes: 1-16-5701 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-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
Z-0594-2019 Class II Cascade Abrazo c-ACT-LR Test Card IVD FOR IN V... Apr 20, 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.