Beckman Coulter Inc. recalls Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU…
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a…
Read the official notice →- Date
- 2026-08-26
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-10-14
USBeckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
- US
Beckman Coulter Inc. recalls DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521…
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system…
- 2026-08-12
- US
Beckman Coulter Inc. recalls REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4…
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE,…Official notice → - 2026-04-29
- US
Beckman Coulter, Inc. recalls Access Total T4 Calibrator, Catalog No. 33805
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-04-15
- US
Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative…
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
FDA · DeviceBeckman Coulter, Inc.International distribution to the country of Poland.Official notice → - US
Beckman Coulter, Inc. recalls MicroScan Neg MIC 3J REF C54814
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
FDA · DeviceBeckman Coulter, Inc.International distribution in the country of Japan.Official notice →
Other drugs & medical recalls in the United States
- 2026-08-26
- US
BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
- US
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
FDA · DeviceBoston Scientific CorporationWorldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment,…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the country of…Official notice → - US
Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
- US
Gentherm Medical, LLC recalls Blanketrol II Model 222S; Thermal regulating system.
Overheating of the 115V CPU board may cause the device to shut down.
FDA · DeviceGentherm Medical, LLCWorldwide - US Nationwide distribution including in the territories of Puerto…Official notice → - US
Paragonix Technologies Inc. recalls Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
FDA · DeviceParagonix Technologies Inc.US Nationwide distribution in the states and territories of AL, AZ, CA, TN,…Official notice →