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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 a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
ProductMicroScan Neg MIC 3J REF C54814
Quantity688 boxes (20 panels per box)
DistributionInternational distribution in the country of Japan.
Initiated2025-06-25
Classified2026-04-03
Recall numberZ-1772-2026
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-1772-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98553/

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