FDA Device recall Z-1853-2012
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots 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-1853-2012 |
| 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 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
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 | Lot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK…Lot # WK0002A WK0003A WK0003B WK0004A WK0005A WK0006A WK0006B WK0006AR WK0006BR WK0007A WK0008A WK0009A WK0010A WK0010B WK0010C WK0011A WK0012A WK0013A WL0001A WL0001B WK0014A WK0015A WL0003A WL0004A WK0016A WL0005A WL0006A WL0007A WK0017A WK0018A WL0007B WL0008A WK0018B WK0018-5A WL0008-5A WL0009A WL0009-5A WK0019A WL0009B WL0010A WL0010-5A WL0010B WL0011-5A WL0011A WL0013A WL0012A WL0012-5A WL0015-5A WL0015A WL0016-5A WL0016A WL0017A WL0018A WL0018-5A WL0019A WL0020A WL0020-5A WL0018B WK0020A WL0021A WL0022A WL0023A WL0023-5A WL0024A WL0024B WL0025A WL0026A WL0026A WL026-5A WL0027 WL0028 WL0029 WL0029A WL0029B WL0030 WL0031 WL0030A WL0033 WL0034 WL0035 WL0036 WL0038 WL0033A WL0039 WL0040 WL0040A WL0041 WL0042 WL0043 WL0044 WL0045 WL0046 WL0045A WL0049 WL0049A WL0051 WL0051A WL0052 WL0053 WL0055 WL0056 WL0057 WL0057A WL0059 WL0060 WL0061 WL0061A WL0062 WL0062A WL0061A WL0063 |
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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-1853-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.