Recall Z-0228-2007 ยท JOZ System, Automated Platelet Aggregation
Accumetrics Inc
VerifyNow P2Y12 Assay Device Kit, Part Number 85054
| Date | Dec 6, 2006 (initiated Sep 5, 2006) |
| Status | Terminated |
| 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 conjunctio |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051231 | VERIFYNOW-P2Y12 ASSAY Accumetrics, Inc., Aug 5, 2005 |