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Beckman Coulter Inc. recall records

96 reported ongoing

99 records in this archive. Latest source date Jul 15, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR,...

Official source
FDA device enforcement

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR,...

Official source
FDA device enforcement

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR,...

Official source
FDA device enforcement

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing de...

Class IIReported ongoing

Distribution: Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spa...

Official source
FDA device enforcement

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the ...

Due to the likely presence of contamination in well(s).

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

Official source
FDA device enforcement

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients ...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.

Official source
FDA device enforcement

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions...

Class IIReported ongoing

Distribution: US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colomb...

Official source
FDA device enforcement

UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the requ...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide.

Official source
FDA device enforcement

Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.

A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the...

Class IIReported ongoing

Distribution: US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands

Official source
FDA device enforcement

DxI 9000 Access Immunoassay Analyzer C11137

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Alger...

Official source
FDA device enforcement

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

Class IIReported ongoing

Distribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapor...

Official source
FDA device enforcement

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in r...

Class IIReported ongoing

Distribution: Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, ...

Official source
FDA device enforcement

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471...

Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn,...

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT...

Official source

Reasons in these listed records

  • Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
  • On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
  • Due to the likely presence of contamination in well(s).
  • Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for ...

These examples come from this result page and are not a ranking of every recall reason.

Checking Beckman Coulter Inc.

Is there a recall on beckman coulter inc. right now?

This archive contains 99 records, including 96 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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