Recall Register

Food, drugs, devices › Firms

Accriva Diagnostics, Inc.

FDA recalling firm · 6 enforcement events · 6 product records · 2022–2026 · CA

Accriva Diagnostics, Inc. has 6 FDA enforcement events on this register (6 product records) between 2022 and 2026: 6 device; the busiest year was 2024 with 2.

0% of its events are Class I; the most common class is Class II (5). 4 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Apr 2026directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2DeviceClass II1Ongoing
5 Nov 2025Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation SystemDeviceClass II1Ongoing
21 Oct 2025VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.DeviceClass III1Ongoing
2 Dec 2024VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064DeviceClass II1Ongoing
27 Sep 2024AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.DeviceClass II1Completed
30 Mar 2022The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen.…DeviceClass II1Terminated

By type and class

Device6
Class II5
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

22
23
24
25
26
Enforcement events for Accriva Diagnostics, Inc. by year initiated.

Questions and answers

How many FDA recalls has Accriva Diagnostics, Inc. had?

6 enforcement events (6 product records) on this register, 2022–2026: 6 device.

Are any Accriva Diagnostics, Inc. recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Accriva Diagnostics, Inc. recalls?

5 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.