Z-0733-2024 Class II Ongoing
FDA device recall Z-0733-2024 was initiated by Greiner Bio-One North America, Inc. on Dec 12, 2023 and is designated Class II. 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 diagnosi… The recall status is ongoing. Affected quantity: 495,600 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 24, 2024
- Initiation Date
- Dec 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 495,600 tubes
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.
Distribution Pattern
US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Code Information
Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.