The Recall Desk
ModerateFDA (Devices)·Z-1854-2012·Announced 2012-06-27

Accumetrics Recalls VerifyNow System for P2Y12 Test Result Changes

Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a field correction to data reporting without mentioning any reported illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Accumetrics Inc is recalling 1,167 units of the VerifyNow System, part #85005-6H, which were distributed nationwide in the United States. The VerifyNow System is a whole blood assay device used in laboratory or point-of-care settings to measure the level of platelet P2Y12 receptor blockade.

The recall was initiated to implement a field correction regarding the results reported when running the VerifyNow P2Y12 Test. Currently, the test reports three values: PRU, BASE, and % Inhibition. The correction involves the elimination of the BASE and % Inhibition results, while the reporting of the PRU result remains unchanged.

Healthcare professionals and institutions using the VerifyNow System should be aware of this change to the reported data. The source text does not specify further instructions for consumers or patients regarding the recall.

The recalled product

Product
VerifyNow System, part #85005-6H 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
Manufacturer
Accumetrics Inc
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
1,167

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 (1)

  • Not available

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Accumetrics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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