Drugs & medicalClass II

Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose…

Read the official notice →
Date
2025-04-30
Country
United States
Brand
Beckman Coulter
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Classification
Class II
Units
Worldwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2025-06-11
  2. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560

    Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result…

    FDA · DeviceBeckman Coulter, Inc.US State: FL. UAE, VietnamOfficial notice →
  3. 2025-05-21
  4. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter…

    Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or…

    FDA · DeviceBeckman Coulter Inc.U.S: AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN , TX, and WI…Official notice →
  5. 2025-05-07
  6. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions:…

    The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

    FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, CA,…Official notice →
  7. 2025-04-16
  8. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or…

    Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

    FDA · DeviceBeckman Coulter, Inc.OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia,…Official notice →
  9. 2025-04-09
  10. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC…

    Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the…

    FDA · DeviceBeckman Coulter Inc.Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID,…Official notice →
  11. 2025-03-26
  12. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

    the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

    FDA · DeviceBeckman Coulter, Inc.US Nationwide. Global Distribution.Official notice →
All 84 Beckman Coulter recalls →

Other drugs & medical recalls in the United States

  1. 2025-04-30
  2. US
    Drugs & medicalClass II

    Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System…

    Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

    FDA · DeviceMicro-X Ltd.US: NJ, WA, Puerto Rico OUS: NoneOfficial notice →
  3. US
    Drugs & medicalClass II

    Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007…

    software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

    FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice →
  4. US
    Drugs & medicalClass II

    Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001,…

    The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the…

    FDA · DeviceAbbott Molecular, Inc.Worldwide - US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware…

    FDA · DeviceIHB OPERATIONS B.V.US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID,…Official notice →
  6. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

    FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide); and OUS (Foreign) to countries of:…Official notice →
  7. US
    Drugs & medicalClass II

    Radiometer Medical ApS recalls Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number…

    ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software…

    FDA · DeviceRadiometer Medical ApSU.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →
See all drugs & medical recalls →