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Device establishmentActive, RegisteredOfficial Action Indicated

BECKMAN COULTER, INC.

BECKMAN COULTER, INC. is an FDA-registered device establishment (FEI 2050012) located in BREA, California. The facility is active, registered. Its most recent FDA inspection on record (2021-08-05) was classified NAI.

Recalls (8)

Jun 26, 2026 Class II
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
OngoingView source data ›
Jan 30, 2026 Class II
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and cali
OngoingView source data ›
Nov 10, 2025 Class II
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
OngoingView source data ›
Jun 26, 2025 Class II
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 t
OngoingView source data ›
Jun 25, 2025 Class II
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-moto
OngoingView source data ›
Jun 12, 2025 Class II
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
OngoingView source data ›
Apr 30, 2025 Class II
A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for
CompletedView source data ›
Apr 23, 2025 Class III
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which co
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
2050012
Address
250 S Kraemer Blvd, BREA, California
Establishment type
Device establishment
Products / operations
Microbiology, Develop Specifications But Do Not Manufacture At This Facility, Clinical Toxicology, Clinical Chemistry, Hematology, Immunology, Pathology, Unknown, Manufacture Medical Device
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Aug 5, 2021 · No Action Indicated (NAI)
Oct 30, 2019 · No Action Indicated (NAI)
Jul 16, 2012 · No Action Indicated (NAI)
May 12, 2011 · Official Action Indicated (OAI)
Feb 8, 2011 · Voluntary Action Indicated (VAI)
Dec 8, 2009 · No Action Indicated (NAI)
Feb 19, 2009 · No Action Indicated (NAI)
Form 483 observations
None on file

FDA record timeline

Recall
Class II — Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Source ›
Recall
Class II — A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and cali
Source ›
Recall
Class II — Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Source ›
Recall
Class II — 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 t
Source ›
Recall
Class II — 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-moto
Source ›
Recall
Class II — 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
Source ›
Recall
Class II — A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for
Source ›
Recall
Class III — The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which co
Source ›
FDA inspection
NAI classification
FDA inspection
NAI classification
FDA inspection
NAI classification
FDA inspection
OAI classification
FDA inspection
VAI classification
FDA inspection
NAI classification
FDA inspection
NAI classification

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is BECKMAN COULTER, INC. registered with the FDA?

Yes. BECKMAN COULTER, INC. is an FDA-registered device establishment (FEI 2050012) in BREA, California. Its current registration status is Active, Registered.

Has BECKMAN COULTER, INC. received an FDA warning letter?

FDA has not posted a warning letter for BECKMAN COULTER, INC.. FDA publishes only a subset of enforcement records, so this is not a guarantee.

What does BECKMAN COULTER, INC. do?

BECKMAN COULTER, INC.'s FDA-registered operations are: Microbiology, Develop Specifications But Do Not Manufacture At This Facility, Clinical Toxicology, Clinical Chemistry, Hematology, Immunology, Pathology, Unknown, Manufacture Medical Device.

Related facilities

Westwood Laboratories, LLC.KC Pharmaceuticals, Inc.Sanitor CorporationImmunityBio, Inc.CellEra, LLCPhillips Precision Inc

Source: FDA public data · status as of 2026-08-22

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