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.
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2026-02-11
USBeckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →- 2026-01-14
- US
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs,…
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - 2025-12-17
- US
Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the…
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could…
- 2025-11-12
- US
Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally…
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading…
- 2025-11-05
- US
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters,…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN,…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-26
- 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
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.
FDA · DeviceCellavision ABUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…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 → - US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor…
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCUSA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice →