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
Dade® PFA Trigger Solution — Siemens Healthcare Diagnostics Products GmbHChrono-log — CHRONO-LOG CORPVerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.PL Chip — ZACROS CORPORATIONChrono-log — CHRONO-LOG CORPVerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Dade® PFA Collagen/ADP Test Cartridge — Siemens Healthcare Diagnostics Products GmbHPL Chip Reservoir Set for T-TAS 01 — ZACROS CORPORATIONCHRONO-LOG — CHRONO-LOG CORPBAPA tube — ZACROS CORPORATIONPlateletworks ADP Kit — HELENA LABORATORIES CORPORATIONChrono-log — CHRONO-LOG CORPHemostasis System — HAEMONETICS CORPORATIONBAPA tube for T-TAS 01 — ZACROS CORPORATIONPlateletworks Combo-25 Kit — HELENA LABORATORIES CORPORATIONChrono-log — CHRONO-LOG CORPChrono-log — CHRONO-LOG CORPTEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATIONVerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Aggreguide — AGGREDYNE, INC.VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.VerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC.Helena Ristocetin — HELENA LABORATORIES CORPORATIONDade® Cluster® Platelet Aggregation Reagents — Siemens Healthcare Diagnostics Products GmbH
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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