FDA Medical Device Recalls (openFDA)
Accumetrics Inc: VerifyNow P2Y12 Assay Device Kit, Part Number 85054
- Recall number
- Z-0228-2007
- Recalling firm
- Accumetrics Inc
- Product
- VerifyNow P2Y12 Assay Device Kit, Part Number 85054
- Status
- Terminated
- Initiated
- 2006-09-05
- Posted
- 2006-12-06
- Terminated
- 2012-03-26
- Reason
- The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
- 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
- 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
- Lot, serial or model codes
- Lot Numbers: WK0002A , WK0003A, WK0003B, WK0004A , WK0005A , WK0006A, WK0006AR, WK0006B, WK0006BR, WK0007A, WK0008A, WK0009A, WK0010A ,WK0010B, 10WK000C, WK0011A, WK0012A and WK0013A
- 510(k) numbers
- ["K051231"]
- PMA numbers
- not on file
- Product code
- JOZ
- Firm FEI
- 3001376288
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28