| Date Initiated by Firm |
March 30, 2022 |
| Create Date |
May 20, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1121-2022 |
| Recall Event ID |
89936 |
| 510(K)Number |
K141427
|
| Product Classification |
System, automated platelet aggregation - Product Code JOZ
|
| 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 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. |
| Code Information |
Lot Number: WL1060, Expiration: 2023-03-01 |
Recalling Firm/
Manufacturer |
Accriva Diagnostics, Inc.
6260 Sequence Dr
San Diego CA 92121-4358
|
| For Additional Information Contact |
858-263-2300
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Employee error |
| Action |
On 03/30/22, recall notices were distributed to customers who were asked to do the following: 1) Forward the notice within their organization and all other organizations where affected devices may have been transferred to. 2) Identify affected devices and do not use. 3) Destroy all affected devices and document the destruction on the Tracking Form. 4) Complete and return the Tracking Form to the recalling firm.
Customers with additional questions can contact Customer Service at 800-955-9525 or e-mail customerservice.na@werfen.com |
| Quantity in Commerce |
11 |
| Distribution |
US Nationwide distribution in the state of California. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = JOZ and Original Applicant = ACCUMETRICS, INC.
|
