Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Beckman Coulter, Inc.

Beckman Coulter, Inc. Recalls

All product recalls associated with Beckman Coulter, Inc..

Get alerts for this brand

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 61–80 of 285 recalls

Beckman Coulter, Inc.: Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

FDAFeb 8, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Access Substrate, REF 81906, For use with the Access Immu...

On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.

FDAFeb 7, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, cat...

1 2 345 6...15

Page 4 of 15Next

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

FDAJan 3, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: iQ200 Series Urine Microscopy Analyzers, Part Numbers: ...

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

FDADec 19, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part ...

FDADec 19, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: iQ Waste Well Adapter, Part Number: 700-3393

FDADec 19, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: REV 2 Flowcell Capsule Spare, Part Number: C04154

FDADec 19, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer running software ver...

There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

FDANov 21, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Access Ultrasensitive Insulin only used on the DxI 9000 A...

There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of IU/mL to the International System of Units (SI units) of pmol/L.

FDANov 21, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware...

The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

FDASep 12, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter Inc.: Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4...

Lipemic interference failed to meet the performance specification listed within the IFU.

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.

Beckman Coulter, Inc.: Access Thyroglobulin Calibrators

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

FDAJul 6, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Ringed DxI Reaction Vessels (RVs)

Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

FDAJun 20, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: COULTER DxH Diluent, REF 628017; diluent used for countin...

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

FDAMay 31, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Reagent lot numbers include an insufficient concentration of blocking reagent.

FDAMay 17, 2023CA, CO, CT +16 more• Beckman Coulter, Inc.

Beckman Coulter, Inc.: UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic...

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

FDAApr 5, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxU 850m Iris Urine Microscopy Analyzer Catalog Number C4...

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

FDAApr 5, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select...

Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.

FDAApr 5, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C...

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

FDAApr 5, 2023Nationwide• Beckman Coulter, Inc.

Beckman Coulter Inc.: Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

FDAApr 5, 2023Nationwide• Beckman Coulter Inc.