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."
Read the official notice →- Date
- 2026-08-12
- Country
- United States
- Brand
- Beckman Coulter
- Product
- REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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…
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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…
- 2026-08-26
- US
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…
- 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
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Other drugs & medical recalls in the United States
- 2026-08-12
- US
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and…
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E)…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide including Puerto Rico and the countries…Official notice → - US
Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy,…
FDA · DeviceHardy DiagnosticsU.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ,…Official notice → - US
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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