VerifyNow P2Y12 Platelet Reactivity Test recall
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Why was VerifyNow P2Y12 Platelet Reactivity Test recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
- Product
- VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Recalling firm
- Accriva Diagnostics, Inc.
- Quantity
- 25
- Distribution
- US Nationwide distribution in the state of VA.
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)