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Recall Observatory FDA recall evidence

Device product

greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

Z-1583-2023

March 31, 2023

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 92025
Status
Completed
Classification
Class II
Quantity
36,000 pieces (30 full cases)
Official record key
device-enforcement:Z-1583-2023

Official wording

Reason: Some of the tubes may be incorrectly labeled.

Code information: Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.

Distribution pattern: US Nationwide distribution in the states of WI and GA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled