RegWardenFDA facility compliance records
Recall

Class II — Beckman Coulter, Inc.

Recalling firmBECKMAN COULTER, INC.
Registered facilityView this company's 22 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonDue to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
ProductMicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Quantity53 plates
DistributionWorldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI MS, MT, NC, NE, PA, SC, TX WA, WI, and WV. The countries of Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, United Kingdom of Great Britain and Northern Ireland, and Uruguay.
Initiated2022-10-03
Classified2022-11-18
Recall numberZ-0269-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Beckman Coulter, Inc. (Z-0269-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90941/

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