RegWardenFDA facility compliance records
Recall

Class II — Greiner Bio-One North America, Inc.

Recalling firmGREINER BIO-ONE NA
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonBlood collection tubes experienced an issue with separation and clotting
ProductVACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.
Quantity1,008,000 pieces
DistributionUS Nationwide distribution including in the states of IL, PA, VA, MO, NY.
Initiated2020-08-28
Classified2020-09-29
Terminated2021-06-17
Recall numberZ-3027-2020
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 — Greiner Bio-One North America, Inc. (Z-3027-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86363/

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