FDA-Device2022-10-26Class II

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.

Becton Dickinson & Company
Hazard

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.

Sold states
Distribution US nationwide, Canada, New Zealand, and Hong Kong.
Affected count
2,196,000
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2023

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