Recall Z-1853-2012— Accumetrics Inc

Name: FDA recall Z-1853-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-06

Class II · Terminated

Class II FDA medical device recall by Accumetrics Inc, initiated 2012-02-06, terminated 2012-11-27. It names one FDA 510(k) clearance: K051231. Product: VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.. Reason: The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic.

Recalling firm: Accumetrics Inc
Classification: Class II
Status: Terminated
Initiated: 2012-02-06
Terminated: 2012-11-27
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051231 — VERIFYNOW-P2Y12 ASSAYAccumetrics, Inc.·cleared 2005-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.

Reason for recall

The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

Data sourced from openFDA. This site is unofficial and independent of the FDA.