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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 261–280 of 285 recalls

Beckman Coulter Inc: Synchron LX Clinical Systems, Operating Software, All ver...

Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.

FDAOct 10, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Coulter DNA Prep Reagents Kit Part 6607055

Labeling Error-Omission of 'Research Use Only'

FDAOct 10, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron LX Clinical Systems Software

'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.

FDAOct 7, 2003Nationwide

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Page 14 of 15Next

• Beckman Coulter Inc

Beckman Coulter Inc: Synchron Systems Lipid Calibrator (HDLD) Part 650218

Incorrect units are printed in labeling but not in software.

FDAOct 3, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron CX4, CX5 and CX9 Pro Systems.

Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.

FDASep 29, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron CX Systems version 4.0 Operating Software used i...

Sample wheel may home to the wrong position.

FDASep 18, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron CX (and) Synchron LX Systems Microalbumin Calibr...

Sample values may be decreased by between 9 and 12 percent.

FDASep 17, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Coulter AcT 5diff Open Vial Hematology Analyzers Part Nu...

Samples with high fat content will not count platelets accurately.

FDASep 8, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Coulter AcT 5diff Cap Pierce Hematology Analyzers Part N...

Samples with high fat content will not count platelets accurately.

FDASep 8, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron Systems Acetaminophen Reagent, part No. 472169.

Firm shortened calibration frequency to 7 days from 14 days.

FDASep 4, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-...

Package insert contains inaccurate information.

FDAAug 26, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.

Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.

FDAAug 18, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Chol...

LDL Cholesterol component in controls are unstable.

FDAAug 15, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Power Processor Aliquot Tube Labels Part 800255

Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.

FDAJun 23, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron LX Systems Primary Tube Sample Template (a piec...

Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.

FDAJun 19, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Access Immunoassay System Technical Update 03.1, Part num...

Defective software media distributed with upgrade software may cause installation failure and systems lock.

FDAJun 18, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenob...

Product was found to produce higher recoveries by about 7-12% compared to other lots.

FDAJun 11, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: IMMAGE IGALC Reagent Part Number: 447460

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: IMMAGE IgM Reagent Part No.: 447610

low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

FDAJun 6, 2003Nationwide• Beckman Coulter Inc

Beckman Coulter Inc: IMMAGE IGMLC Reagent Part Number: 447470

Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

FDAJun 6, 2003Nationwide• Beckman Coulter Inc