--- title: "Accriva Diagnostics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Accriva Diagnostics, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/accriva-diagnostics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Accriva Diagnostics, Inc. recall records **4** reported ongoing 6 records in this archive. Latest source date Apr 30, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 30, 2026 FDA device enforcement ### [directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2](https://isitonrecall.com/recall/fda-device-z-2460-2026-directcheck-act-lr-whole-blood-quality-control-level-2-model-catalog-number-dcglr-2/) Assayed Whole blood control contains labeling with incorrect performance range. Class II Reported ongoing 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,... [Official source for directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2460-2026%22) Nov 5, 2025 FDA device enforcement ### [Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System](https://isitonrecall.com/recall/fda-device-z-0880-2026-hemochron-activated-clotting-time-low-range-test-cuvette-ref-act-lr-to-be-used-with-the-hemochron-si/) 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 II Reported ongoing 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 coun... [Official source for Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemoch...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0880-2026%22) Oct 21, 2025 FDA device enforcement ### [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 m...](https://isitonrecall.com/recall/fda-device-z-0500-2026-verifynow-prutest-platelet-reactivity-test-ref-85225-udi-di-code-10711234150078-the-verifynow-prutes/) Due to an device without a premarket clearance being incorrectly package and distributed. Class III Reported ongoing 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. [Official source for VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PR...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0500-2026%22) Dec 2, 2024 FDA device enforcement ### [VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064](https://isitonrecall.com/recall/fda-device-z-0961-2025-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 inhibition formula in the notice to manually... Class II Reported ongoing Distribution: US Nationwide distribution in the state of VA. [Official source for VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0961-2025%22) Sep 27, 2024 FDA device enforcement ### [AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.](https://isitonrecall.com/recall/fda-device-z-0279-2025-avoximeter-1000e-product-number-avox1000e-the-avoximeter-1000e-is-a-battery-operated-bedside-whole-b/) 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 medica... Class II Reported completed Distribution: US: AZ [Official source for AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside w...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0279-2025%22) Mar 30, 2022 FDA device enforcement ### [The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyri...](https://isitonrecall.com/recall/fda-device-z-1121-2022-the-verifynow-p2y12-test-is-designed-to-measure-platelet-p2y12-receptor-blockade-substances-known-to/) 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 m... Class II Reported terminated Distribution: US Nationwide distribution in the state of California. [Official source for The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances know...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1121-2022%22) ## Reasons in these listed records - Assayed Whole blood control contains labeling with incorrect performance range. - 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. - Due to an device without a premarket clearance being incorrectly package and distributed. - 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 perce... These examples come from this result page and are not a ranking of every recall reason. ## Checking Accriva Diagnostics, Inc. ### Is there a recall on accriva diagnostics, inc. right now? This archive contains 6 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Accriva Diagnostics, Inc.](https://isitonrecall.com/check/?q=Accriva%20Diagnostics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)