System, Automated Platelet Aggregation

VerifyNow PRUTest Platelet Reactivity Test REF 85225

Due to an device without a premarket clearance being incorrectly package and distributed.

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit.

Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.

VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310,

Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.

VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots.

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

VerifyNow System, part #85005-6H

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

VerifyNow P2Y12 Assay Device Kit, Part Number 85054

The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

Accumetrics part number 29001 VerifyNow Instrument, printe power supply

In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

VerifyNow Asprin Assay Kit

Test results too low in control.

The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor a

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.