FDAClass IIAugust 21, 2019

BD Vacutainer Fluoride Tubes for Blood Alcohol recall

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

Why was BD Vacutainer Fluoride Tubes for Blood Alcohol recalled?

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)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100

Product
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Recalling firm
Becton Dickinson & Company
Quantity
247,000 tubes
Distribution
US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Recall date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls