VerifyNow System
VerifyNow System Electronic Quality Control Device
1manufacturer
12catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
Record
| Listed by | Accriva Diagnostics, Inc., United States |
|---|---|
| FDA product code | JOZ |
| Device type | System, Automated Platelet Aggregation |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5700 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K992531 |
| Record published | 2016-09-22 |
| Record revised | 2022-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 59 to 77 °F; Storage environment temperature 15 to 25 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 86000 | In distribution | ||
| 86003 | In distribution | ||
| 85062 | In distribution | ||
| 85021 | In distribution | ||
| 86000RF | In distribution | ||
| 86003L | In distribution | ||
| 86000D | In distribution | ||
| 85047 | 6 | In distribution | |
| 86000L | In distribution | ||
| 70068 | In distribution | ||
| 86003D | In distribution | ||
| 85063 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chrono-log | Chrono-LOG Corp. | 10 |
| TEG6s Hemostasis System | Haemonetics Corporation | 5 |
| VerifyNow Platelet Reactivity Test | Accriva Diagnostics, Inc. | 4 |
| TEG Hemostasis System | Haemonetics Corporation | 3 |
| TEG5000 Hemostasis System | Haemonetics Corporation | 3 |
| AggRecetin | Bio/Data Corp. | 2 |
| Aggreguide | Aggredyne, Inc. | 2 |
| Plateletworks Combo-25 Kit | Helena Laboratories, Corp. | 1 |
| Epinephrine | Bio/Data Corp. | 1 |
| Bapa tube | Zacros Corporation | 1 |
| T-TAS 01 Total Thrombus Formation Analysis System | Zacros Corporation | 1 |
| PL Chip for T-TAS 01 | Zacros Corporation | 1 |
Showing 12 of 34. All products under System, Automated Platelet Aggregation
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Accumetrics, Inc. | 510(k) number | 2014-02-13 | Class II | Nonconforming Material/Component | 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 result may cause a low percent inhibition calculation or low base | 576 units total (524 units in US) | 2014-08-23 |
| Accumetrics, Inc. | 510(k) number | 2013-11-14 | Class II | Other | 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 patient sample. The correct instruction is to perform the tes | 69 units | 2013-12-23 |
| Accumetrics, Inc. | 510(k) number | 2005-09-13 | Not classified | Other | In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply. | 11 | 2007-03-03 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-10-21 | Class III | Under Investigation by firm | Due to an device without a premarket clearance being incorrectly package and distributed. | 125 boxes (3,125 tests) | |
| 2024-12-02 | Class II | Process control | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the n | 25 | |
| 2022-03-30 | Class II | Employee error | 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 clearance was distributed and it displays BASE results not displaye | 11 | 2024-11-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.