Z-0095-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,196,000
Product Description
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Reason for Recall
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Distribution Pattern
Distribution US nationwide, Canada, New Zealand, and Hong Kong.
Code Information
UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.