Accriva Diagnostics recalls
6 official recalls and safety alerts involving Accriva Diagnostics since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Accriva Diagnostics or the relevant agency.
- 2026-06-24
USAccriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Assayed Whole blood control contains labeling with incorrect performance range.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-12-10
- US
Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood…
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.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of OH, IL, NY,…Official notice → - 2025-11-19
- US
Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in…
Due to an device without a premarket clearance being incorrectly package and distributed.
FDA · DeviceAccriva Diagnostics, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL,…Official notice → - 2025-01-22
- US
Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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…
FDA · DeviceAccriva Diagnostics, Inc.US Nationwide distribution in the state of VA.Official notice → - 2024-11-06
- US
Accriva Diagnostics, Inc. recalls AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
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…
- 2022-06-01
- US
Accriva Diagnostics, Inc. recalls The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12…
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…
FDA · DeviceAccriva Diagnostics, Inc.US Nationwide distribution in the state of California.Official notice →