FDA recall Z-0733-2024

Greiner Bio-One North America, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-12-12
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0733-2024