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Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

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Recall Summary

Total Recalls

285

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 285 recalls

Beckman Coulter Inc.: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Prod...

The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

FDADec 30, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: MicroScan Pos MIC Panel Type 34 - Product Usage: For the ...

Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

FDADec 2, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: BECKMAN COULTER ACCESS Immunoassay Systems - Access Uncon...

Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

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FDAAug 26, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; ...

The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.

FDAAug 18, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: iQ200 Series Urine Microscopy Analyzer- All part numbers

A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

FDAMar 30, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: iChemVELOCITY Urine Chemistry System-

A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

FDAMar 30, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter, Inc.: iChemVELOCITY Strips, Catalog 800-7212

The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

FDAFeb 17, 2020IN, PR• Beckman Coulter, Inc.

Beckman Coulter Inc.: ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, U...

Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.

FDAJan 29, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: LabPro Data Management System, UDI: 15099590676872 - Prod...

A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.

FDAJan 17, 2020Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Beckman Coulter MicroScan PROMPT Inoculation System-D, Ca...

Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.

FDADec 13, 2019Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: iChem VELOCITY Urine Chemistry Analyzer

Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

FDANov 7, 2019Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: iQ200 Series Urine Microscopy Analyzer, Catalog numbers: ...

Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

FDAOct 28, 2019Nationwide• Beckman Coulter Inc.