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.
Read the official notice →- Date
- 2025-12-10
- Country
- United States
- Brand
- Accriva Diagnostics
- Product
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of OH, IL, NY,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Accriva Diagnostics recalls
- 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 →- 2025-11-19
- 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 →
Other drugs & medical recalls in the United States
- 2025-12-10
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Philips Ultrasound, LLC recalls Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
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Philips North America Llc recalls CT 5300; Software Version Number: 4.5, 5.0, 5.1;
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Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AR, CA, NY and the…Official notice → - US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
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Aizu Olympus Co., Ltd. recalls Olympus OER-Elite
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