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Recall Observatory FDA recall evidence

Device product

VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

Z-0733-2024

December 12, 2023

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 93606
Status
Ongoing
Classification
Class II
Quantity
495,600 tubes
Official record key
device-enforcement:Z-0733-2024

Official wording

Reason: Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

Code information: Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.

Distribution pattern: US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.