FDA Enforcement
Class II
Ongoing
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Recall: Z-0733-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0733-2024
- Event ID
- 93606
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Greiner Bio-One North America, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 12, 2023
- Classification Date
- January 16, 2024
- Address
- 4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States
Description
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.
Code Info
Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.
Distribution
US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Quantity
495,600 tubes