Cellavision AB recalls REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5…
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Cellavision AB
- Product
- REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2025-11-26
USMeridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
FDA · DeviceMeridian Bioscience IncUS Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN,…Official notice →- US
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
FDA · DeviceASP Global, LLC. dba Anatomy Supply Partners, LLC.Distribution US nationwide and Canada.Official notice → - US
Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
FDA · DeviceAuris Health, IncNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, MA,…Official notice → - US
Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro…
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY,…Official notice → - US
Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is…
Due to incorrect product label (Incorrect product name identified on outer packaging).
FDA · DeviceBerkeley Advanced Biomaterials, LLCU.S. Nationwide distribution in the state of TN.Official notice → - US
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
FDA · DeviceMedtronic Perfusion SystemsUS Nationwide distribution in the states of Hawaii and New York.Official notice →