Drugs & medicalClass II

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…

Read the official notice →
Date
2025-10-29
Country
United States
Brand
Beckman Coulter
Product
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Classification
Class II
Units
Worldwide - US Nationwide distribution.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2025-11-12
  2. US
    Drugs & medicalClass II

    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 →
  3. US
    Drugs & medicalClass II

    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…

    FDA · DeviceBeckman Coulter, Inc.WorldwideOfficial notice →
  4. 2025-11-05
  5. US
    Drugs & medicalClass II

    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 →
  6. 2025-10-15
  7. US
    Drugs & medicalClass II

    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 →
  8. 2025-10-08
  9. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…

    On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…

    FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →
  10. 2025-09-24
  11. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

    Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

    FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2025-10-29
  2. US
    Drugs & medicalClass II

    Theken Companies LLC recalls iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head…

    Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

    FDA · DeviceTheken Companies LLCUS Nationwide distribution in the states of NJ, PA, and TX.Official notice →
  3. US
    Drugs & medicalClass III

    Home Health US, Incorporated recalls One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is…

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

    FDA · DeviceHome Health US, IncorporatedU.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL,…Official notice →
  4. US
    Drugs & medicalClass II

    UIH Technologies LLC recalls Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

    Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

    FDA · DeviceUIH Technologies LLCUS: OUS:Official notice →
  5. US
    Drugs & medicalClass II

    Wipro GE Healthcare Private Ltd. recalls GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical…

    Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs…

    FDA · DeviceWipro GE Healthcare Private Ltd.Worldwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Biomet, Inc. recalls BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

    There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

    FDA · DeviceBiomet, Inc.Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA…Official notice →
  7. US
    Drugs & medicalClass II

    Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3…

    Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

    FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
See all drugs & medical recalls →