Becton Dickinson & Company: BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations

Is my product affected?

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

• UPC 30382903670018

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling BD Vacutainer Fluoride Tubes (Part Number 367001) used for blood alcohol testing. Lot Number 8187663 (expiration date July 31, 2020) was found to contain no additive preservative in the tubes. Approximately 247,000 tubes were distributed nationwide in California, Florida, Georgia, Illinois, Kansas, Missouri, Pennsylvania, Rhode Island, Tennessee, and Canada. When samples are processed without the preservative and stored at room temperature for two days or less, test results are reliable. However, if samples were stored for more than two days, blood alcohol test results may be inaccurate, showing results that are either falsely low or falsely high.

The source document does not specify a remedy or any action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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)

Details from the source

Reason for recall: 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) Distribution: US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada Quantity: 247,000 tubes Lot/code info: Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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