FDA recall Z-0095-2023

Becton Dickinson & Company · Class II · device

Product

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

Distribution US nationwide, Canada, New Zealand, and Hong Kong.

Key facts

Status
Ongoing
Initiation date
2022-09-15
Report date
2022-10-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Franklin Lakes, NJ, United States

Primary source

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