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…
Read the official notice →- Date
- 2025-11-12
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
- Classification
- Class II
- Units
- Worldwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-12-17
USBeckman 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…
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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 → - 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 → - 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 → - 2025-10-29
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering…
- 2025-10-15
- US
Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
FDA · DeviceBeckman Coulter Inc.US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico SingaporeOfficial notice →
Other drugs & medical recalls in the United States
- 2025-11-12
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Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID,…Official notice → - US
Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
FDA · DeviceTotal Joint Orthopedics, Inc.US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and…Official notice → - US
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FDA · DeviceTandem Diabetes Care, Inc.US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - US
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A potential issue with the seal integrity of header bag packaging.
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Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F…
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for…