FDA Device recall Z-1854-2012
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of…
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of… by Accumetrics, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1854-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-06 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Accumetrics |
| Distribution | US |
Product
VerifyNow System, part #85005-6H 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
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
Identifiers
| code_info | Not available |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2012%22
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