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.
Read the official notice →- Date
- 2025-11-19
- Country
- United States
- Brand
- Accriva Diagnostics
- Product
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the…
- Classification
- Class III
- Units
- Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2025-12-10
- 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 → - 2025-01-22
- 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
- 2025-11-26
- US
- US
Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals…
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- 2025-11-19
- US
TECHNO-PATH MANUFACTURING LTD. recalls Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to…
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
FDA · DeviceTECHNO-PATH MANUFACTURING LTD.US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX,…Official notice → - US
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems…
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
FDA · DeviceSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Applied Medical Technology Inc recalls Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I
The nasal feeding tube may be occluded
FDA · DeviceApplied Medical Technology IncUS Nationwide distribution in the states of MA, RI, NC, OH.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice →