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

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 41–60 of 96 recalls

Access Intact PTH Assay (Beckman Coulter) – Reagent Dispense Issue (2024)

Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

Moderate

FDANov 26, 2024Nationwide• Beckman Coulter, Inc.

Access hsTnI Reagent (Beckman Coulter) – Troponin Level (2024)

Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.

Moderate

FDANov 18, 2024Nationwide• Beckman Coulter, Inc.

1 234 5

Page 3 of 5Next

DxI 9000 Access Analyzer (Beckman Coulter) – Wash Wheel Issue (2024)

The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

Moderate

FDANov 13, 2024Nationwide• Beckman Coulter, Inc.

Access Intact PTH Assay (Beckman Coulter) – Sample Storage Issue (2024)

The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.

Moderate

FDANov 8, 2024Nationwide• Beckman Coulter Inc.

Access Cortisol Assay (Beckman Coulter) – Calibration Curve Error (2024)

The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.

Moderate

FDASep 30, 2024Nationwide• Beckman Coulter, Inc.

Access Thyroglobulin Antibody (Beckman) – Result Accuracy Issue (2024)

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Moderate

FDASep 5, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: The Access TSH (3rd IS) assay is a paramagnetic particle,...

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

Moderate

FDAAug 28, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter Inc.: IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reage...

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

Moderate

FDAJul 31, 2024AZ, CA, CO +12 more• Beckman Coulter Inc.

Beckman Coulter, Inc.: Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls...

Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

Moderate

FDAJul 16, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, catalog number C111...

Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

Moderate

FDAJul 12, 2024Nationwide• Beckman Coulter, Inc.

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

Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

Moderate

FDAJul 10, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Discrete photometric chemistry analyzer for clinical use.

Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.

Moderate

FDAJun 14, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.

Moderate

FDAJun 4, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter Inc.: Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal

Moderate

FDAMay 27, 2024Nationwide• Beckman Coulter Inc.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

Moderate

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

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

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

Moderate

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro di...

Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.

Moderate

FDAApr 18, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF...

When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

Moderate

FDAApr 18, 2024FL, GA, IN +6 more• Beckman Coulter, Inc.

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

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

Moderate

FDAMar 5, 2024Nationwide• Beckman Coulter, Inc.

Beckman Coulter, Inc.: Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a...

Laceration Risk

The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.

Very High

FDAFeb 29, 2024Nationwide• Beckman Coulter, Inc.