VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accriva Diagnostics, Inc.
- Reason for Recall:
- Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Product Codes/Lot Numbers:
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0961-2025
Related Recalls
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Accriva Diagnostics
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Due to an device without a premarket clearance being incorrectly package and distributed.
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Accriva Diagnostics
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.