Home › Device types › JOZ
System, Automated Platelet Aggregation
FDA product code JOZ · Class 2 · Hematology
70
Registered devices
77
Adverse events
11
Recalls
38
510(k) clearances
Devices with this code
AggRecetin — Bio/Data CorporationDade® PFA Trigger Solution — Siemens Healthcare Diagnostics Products GmbHVerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC.BAPA tube for T-TAS 01 — ZACROS CORPORATIONPL Chip Reservoir Set — ZACROS CORPORATIONPlateletworks Combo-25 Kit — HELENA LABORATORIES CORPORATIONVerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.PFA-100® System — Siemens Healthcare Diagnostics Products GmbHVerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Dade® PFA Collagen/EPI Test Cartridge — Siemens Healthcare Diagnostics Products GmbHPlateletworks Combo-10 Kit — HELENA LABORATORIES CORPORATIONAGG/PAK 5 Combo Kit — Bio/Data CorporationPlateletworks Collagen Kit — HELENA LABORATORIES CORPORATIONTEG6s HEMOSTASIS SYSTEM — HAEMONETICS CORPORATIONVerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Collagen — Bio/Data CorporationT-TAS 01 Total Thrombus Formation Analysis System — ZACROS CORPORATIONChrono-log — CHRONO-LOG CORPPL Chip for T-TAS 01 — ZACROS CORPORATIONArachidonic Acid — Bio/Data CorporationHemostasis System — HAEMONETICS CORPORATIONDade® PFA Collagen/ADP Test Cartridge — Siemens Healthcare Diagnostics Products GmbHAggreguide — AGGREDYNE, INC.VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-21 | Accriva Diagnostics, Inc. | Due to an device without a premarket clearance being incorrectly package and distributed. |
| 2024-12-02 | Accriva Diagnostics, Inc. | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior |
| 2022-03-30 | Accriva Diagnostics, Inc. | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without U |
| 2019-07-23 | Aggredyne, Inc. | The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 bein |
| 2014-02-13 | Accumetrics Inc | Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An err |
| 2013-11-14 | Accumetrics Inc | Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following |
| 2012-02-06 | Accumetrics Inc | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y1 |
| 2012-02-06 | Accumetrics Inc | The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y1 |
| 2006-09-05 | Accumetrics Inc | The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run. |
| 2005-09-13 | Accumetrics Inc | In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply. |
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