FDA-Device2019-08-21Class II

BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations

Becton Dickinson & Company
Hazard

Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)

Sold states
US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Affected count
247,000 tubes
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2019

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