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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
StatusTerminated
ReasonThe Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
ProductiChemVELOCITY Strips, Catalog 800-7212
Quantity10822 vials
DistributionDistribution in US including Puerto Rico, Canada, and Taiwan
Initiated2020-02-17
Classified2020-03-20
Terminated2021-05-13
Recall numberZ-1535-2020
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-1535-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85047/

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