The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block
Summary
The FDA issued a Class II for The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade by Accriva Diagnostics, Inc.. Reason: Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test.
Details
Source
Device Recall
External ID
Z-1121-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
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 activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ¿M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.
Lot/Code Info: Lot Number: WL1060, Expiration: 2023-03-01
Quantity Affected: 11
Reason for Recall
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.
Distribution
US Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-30
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accriva Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accriva Diagnostics, Inc. have FDA actions?
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1121-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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