Device establishmentActive, RegisteredFDA warning letter on file

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. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 15, 2024

CGMP/QSR/Medical Devices/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (8)

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

Ongoing

Nov 10, 2025 Class II

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Ongoing

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

Ongoing

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

Ongoing

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

Ongoing

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

Ongoing

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

Ongoing

Nov 26, 2024 Class II

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, riskin

Ongoing

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

Clinical Chemistry, Develop Specifications But Do Not Manufacture At This Facility

Registration status

Active, Registered

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Aug 5, 2021 · No Action Indicated (NAI)
Aug 5, 2021 · No Action Indicated (NAI)
Oct 30, 2019 · No Action Indicated (NAI)
Oct 30, 2019 · No Action Indicated (NAI)
Jul 16, 2012 · No Action Indicated (NAI)
Jul 16, 2012 · No Action Indicated (NAI)
May 12, 2011 · Official Action Indicated (OAI)
May 12, 2011 · Official Action Indicated (OAI)
Feb 8, 2011 · Voluntary Action Indicated (VAI)
Dec 8, 2009 · No Action Indicated (NAI)
Dec 8, 2009 · No Action Indicated (NAI)
Feb 19, 2009 · No Action Indicated (NAI)

Form 483 observations

None on file

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?

Yes. FDA issued a warning letter to BECKMAN COULTER, INC.; the most recent is dated Mar 15, 2024 (CGMP/QSR/Medical Devices/Adulterated).

What does BECKMAN COULTER, INC. do?

BECKMAN COULTER, INC.'s FDA-registered operations are: Clinical Chemistry, Develop Specifications But Do Not Manufacture At This Facility.

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Source: FDA public data · status as of 2026-06-06