Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1853-2012 — 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 b

U.S. FDA — Device Enforcement · United States · 2012-02-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1853-2012
Date of alert: 2012-02-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accumetrics Inc
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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