Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0733-2024 — VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

U.S. FDA — Device Enforcement · United States · 2023-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0733-2024
Date of alert
2023-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Greiner Bio-One North America, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
39120017575130
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.