San Diego, CA, United States
Accriva Diagnostics, Inc. recalls
6 recalls recorded since 2018, most recently on 30 April 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)4
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 April 2026
- Reason
- Assayed Whole blood control contains labeling with incorrect performance range.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2460-2026
- directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Ongoing Class II Medical devices
- Recall started
- 5 November 2025
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0880-2026
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Ongoing Class III Medical devices
- Recall started
- 21 October 2025
- Reason
- Due to an device without a premarket clearance being incorrectly package and distributed.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0500-2026
- VerifyNow 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 rece
Ongoing Class II Medical devices
- Recall started
- 2 December 2024
- Reason
- 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 percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
- Distribution
- US Nationwide distribution in the state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0961-2025
- VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Completed Class II Medical devices
- Recall started
- 27 September 2024
- Reason
- 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.
- Distribution
- US: AZ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0279-2025
- AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Terminated Class II Medical devices
- Recall started
- 30 March 2022
- Terminated
- 7 November 2024
- Reason
- 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 formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.
- Distribution
- US Nationwide distribution in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1121-2022
- The 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.