Accumetrics Recalls VerifyNow P2Y12 Assay for Field Correction
Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.
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 the VerifyNow P2Y12 Assay, Part Number 85064, for all reagent lots. The recall involves 26,075 units that were distributed nationwide in the United States. The product is a whole blood assay 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 to the VerifyNow System. Specifically, the change eliminates the reporting of the BASE and % Inhibition results. The reporting of the PRU result will not change. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare professionals and institutions using the VerifyNow System should contact Accumetrics for assistance regarding the field correction. The source text does not provide specific consumer instructions or a contact number.
The recalled product
- 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 us
- Manufacturer
- Accumetrics Inc
- Hazard
- Affected units
- 26,075
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 →Related recalls
Same manufacturer · Accumetrics Inc
See all →- HighAccumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Erroneous Results
FDA (Devices) · 2014-03-19
- ModerateAccumetrics Recalls VerifyNow IIb/IIIa Test Kits Due to Incorrect Instructions
FDA (Devices) · 2013-12-18
- ModerateAccumetrics Recalls VerifyNow System for P2Y12 Test Result Changes
FDA (Devices) · 2012-06-27