Home › ZACROS CORPORATION › PL Chip Reservoir Set for T-TAS 01
PL Chip Reservoir Set for T-TAS 01
ZACROS CORPORATION · Model N/A · UDI-DI 04589448510044
JOZ
Prescription
1
510(k) clearances
77
Adverse events (1 deaths)
11
Recalls
17
Facilities
Description
Disposable accessories for use with the PL Chip for T-TAS 01, 100 sets
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 to initiating drug t |
| 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 US-FDA market clearan |
| 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 being erased. Due to thi |
| 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 erroneous low PAU resul |
| 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 collection of the pa |
| 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 P2Y12 Test. Currently t |
| 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 P2Y12 Test. Currently t |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.