Z-0228-2007

VerifyNow P2Y12 Assay Device Kit, Part Number 85054

Name: Z-0228-2007 VerifyNow P2Y12 Assay Device Kit, Part Number 85054
Creator: Accumetrics Inc
Published: 2006-09-05
License: https://open.fda.gov/license/

Accumetrics, Inc. / initiated 2006-09-05 / Terminated

FDA source

Accumetrics Inc began a recall of VerifyNow P2Y12 Assay Device Kit, Part Number 85054 on 2006-09-05. The reason FDA records is "The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0228-2007
Status: Terminated
Initiated: 2006-09-05
Posted: 2006-12-06
Terminated: 2012-03-26
Recalling firm: Accumetrics, Inc.
Product: VerifyNow P2Y12 Assay Device Kit, Part Number 85054
Product code: JOZ System, Automated Platelet Aggregation
Reason for recall: The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
FDA root cause: Other
Action: The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter. The notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.
Quantity in commerce: 333
Distribution: Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom
Product codes and lots: Lot Numbers: WK0002A , WK0003A, WK0003B, WK0004A , WK0005A , WK0006A, WK0006AR, WK0006B, WK0006BR, WK0007A, WK0008A, WK0009A, WK0010A ,WK0010B, 10WK000C, WK0011A, WK0012A and WK0013A

Product code JOZ

K051231Class IIVerifynow-P2y12 AssayAccumetrics, Inc. / cleared 2005-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)