Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves an unclearred device variant with no mentioned illnesses or injuries. Per the rubric, a risk-of-harm medical device with no reported injury falls under High (3).
Plain-English summary
Accriva Diagnostics is recalling lot WL1060 (expiration March 1, 2023) of the VerifyNow P2Y12 Test. A variant of this platelet reactivity test without U.S. FDA market clearance was distributed instead of the FDA-cleared version.
The unclearred device displays BASE results not shown on the FDA-cleared device. This creates a mismatch between the results produced and what healthcare providers expect from the approved version.
Healthcare facilities should stop using the unclearred device. Accriva has provided a formula to healthcare personnel to calculate the percentage of platelet aggregation inhibition for any results already obtained from the unclearred version.
The recalled product
- Product
- The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of…
- Manufacturer
- Accriva Diagnostics, Inc.
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: WL1060
- Expiration: 2023-03-01
Distribution
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