Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the…
Read the official notice →- Date
- 2025-06-18
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
- Classification
- Class II
- Units
- Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-07-23
USBeckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a…
FDA · DeviceBeckman Coulter, Inc.International distribution to the country of Andorra, Bulgaria, Denmark,…Official notice →- 2025-07-02
- US
Beckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may…
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR,…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI,…Official notice → - 2025-06-11
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice → - US
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…
- 2025-05-21
- US
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 →
Other drugs & medical recalls in the United States
- 2025-06-18
- US
Copan Italia recalls BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Swabs for specimen collection may be prone to breakage during product usage.
- US
Philips North America recalls Intera 1.5T Achieva Nova-Dual Product Number: 781173;
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the…
FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI,…Official notice → - US
QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the…
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
FDA · DeviceQUANTUM SURGICAL SASWorldwide distribution - U.S. Nationwide distribution in the states of FL,IL,…Official notice → - US
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box)…
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
FDA · DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)Worldwide distribution - US Nationwide including Puerto Rico (PR) and OUS…Official notice → - US
Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac…
FDA · DeviceMedtronic, Inc.International distribution of the country of UK. No US distribution.Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…Official notice →