VerifyNow P2Y12 Assay — Class II medical device recall Z-1853-2012
Terminated recall by Accumetrics Inc, reported 2012-06-27, distributed nationwide. The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically th
| Recall number | Z-1853-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accumetrics Inc, San Diego, CA, United States |
| Recall initiated | 2012-02-06 |
| Classified | 2012-06-21 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 26,075 units |
| Lot numbers | WK0002A, WK0003A, WK0003B, WK0004A, WK0005A, WK0006A, WK0006AR, WK0006B, WK0006BR, WK0007A, WK0008A, WK0009A, WK0010A, WK0010B, WK0010C, WK0011A, WK0012A, WK0013A, WK0014A, WK0015A, WK0016A, WK0017A, WK0018-5A, WK0018A, WK0018B, WK0019A, WK0020A, WL0001A, WL0001B, WL0003A, WL0004A, WL0005A, WL0006A, WL0007A, WL0007B, WL0008-5A, WL0008A, WL0009-5A, WL0009A, WL0009B and 109 more |
| Model numbers | 85064 |
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 use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1853-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.