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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

39

Class I (Serious)

0

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 141–160 of 285 recalls

Beckman Coulter Inc.: Access 2 Immunoassay Systems, Catalog No. 81600N, 386220,...

Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.

Class IIModerate

FDAOct 6, 2014Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Coulter DxH Diluent, Catalog No. 628017 Blood cell ana...

Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.

Class IIModerate

FDAAug 25, 2014Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: UniCel 600/800 Access Immunoassay Systems are in vitro di...

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Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi

Class IIModerate

FDAAug 21, 2014Nationwide• Beckman Coulter Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: MicroScan Microbiology Systems: Dried Gram Negative MIC/C...

Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

Class IIModerate

FDAAug 8, 2014Nationwide• Beckman Coulter, Inc.

Beckman Coulter Inc.: Beckman Coulter Access Free T3 Calibrators, Part Number A...

Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.

FDADec 17, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Access Immunoassay Systems enhanced AccuTnl Reagent Kit, ...

The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced Access Accu Tnl assay (P/N A 78033): (1) Access Total BhCG (P/N 33500); (2) Access HYPERsensitive hTSH/Fast hTSH (P/N 33820); (3) Access hFSH (P/N 33520). The issue can occur only when the assays are

FDADec 10, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # ...

The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.

FDADec 8, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: UniCel DxH 800 Coulter Cellular Analysis System, Part Num...

The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.

FDADec 8, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel...

This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument

FDAOct 28, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Synchron CX Immuno-Protein Cal, part number: 442840, ot...

A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330.

FDAAug 26, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 46960...

The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.

FDAAug 11, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Synchron Phenobarbital (PHE) Reagent, P/N 469785, Class...

The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.

FDAAug 11, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10...

The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio

FDAAug 3, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Unicel DxH 800 Coulter Cellular Analysis System, Part num...

The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.

FDAJul 28, 2009Nationwide• Beckman Coulter Inc.