Facility

Accriva Diagnostics, Inc.

7 recall(s) on record — most severe on record: Class II.

Key facts

7recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2250033
Establishment type	Manufacture Medical Device
Location	6260 Sequence Drive San Diego, CA, US 92121
Registration status	Active · expires 2026
Parent company	Accriva Diagnostics, Inc. (owner-operator 10048042)
Brand names	85062 - Preventative Maintenance Kit; 86000 - VerifyNow Instrument; 86000RF - VerifyNow Instrument; 86003L - VerifyNow Instrument; 85047 - WQC; 86003D - VerifyNow Instrument; 86003 - VerifyNow Instrument; 85063 - Validation Kit; 70068 - EQC; 86000D - VerifyNow Instrument; 86000L - VerifyNow Instrument

Activity by year

Recalls (7)
Inspections (2)

Devices registered here (1)

System, Automated Platelet Aggregation
Product code JOZ (opens in a new tab) · Class II · Hematology · 21 CFR 864.5700

Recalls & enforcement

Class IIOngoing2026-04-30
Assayed Whole blood control contains labeling with incorrect performance range.
Class IIOngoing2025-11-05
Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
Class IIIOngoing2025-10-21
Due to an device without a premarket clearance being incorrectly package and distributed.
Class IIOngoing2024-12-02
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 notice to manually calculate the percenta…
Class IICompleted2024-09-27
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
Class IITerminated2022-03-30
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 displayed by the US-FDA market cleared device. A…
Class IITerminated2016-04-22
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

FDA inspections (2)

NAI2024-07-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-01-18
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Accriva Diagnostics, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Accriva Diagnostics, Inc. (FEI 2250033) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2250033-accriva-diagnostics-inc/

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