VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole b...
FDA Device Recall #Z-1854-2012 — Class II — February 6, 2012
Recall Summary
| Recall Number | Z-1854-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 6, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Accumetrics Inc |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 1,167 units total |
Product Description
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Reason for Recall
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Not available
Other Recalls from Accumetrics Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1172-2014 | Class II | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-... | Feb 13, 2014 |
| Z-0482-2014 | Class II | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog N... | Nov 14, 2013 |
| Z-1853-2012 | Class II | VerifyNow P2Y12 Assay, Part Number: 85064, All ... | Feb 6, 2012 |
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.