Recall Z-0733-2024— Greiner Bio-One North America, Inc.

Name: FDA recall Z-0733-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-12

Class II · Ongoing

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2023-12-12. It names one FDA 510(k) clearance: K971239. Product: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.. 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..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-12
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971239 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.