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Recall Observatory FDA recall evidence

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.

Z-0095-2023

September 15, 2022

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 90824
Status
Ongoing
Classification
Class II
Quantity
2,196,000
Official record key
device-enforcement:Z-0095-2023

Official wording

Reason: 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.

Code information: UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.