BD Vacutainer Fluoride Tubes Recalled Due to Missing Preservative Additive
Becton Dickinson is recalling 247,000 blood alcohol test tubes because they lack the required fluoride additive, which may cause inaccurate test results if samples are stored for more than two days.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for blood alcohol determinations where the defect (missing additive) can lead to inaccurate test results (falsely low or high) if samples are stored for more than two days. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported, as inaccurate blood alcohol results can have significant legal and medical implications.
Plain-English summary
Becton Dickinson & Company is recalling 247,000 units of BD Vacutainer Fluoride Tubes for Blood Alcohol determinations (Part Number 367001). The recall is due to a manufacturing error where the tubes were confirmed to contain no additive (preservative). The affected lot number is 8187663, with an expiration date of July 31, 2020.
The missing additive affects the reliability of blood alcohol test results depending on storage conditions. If samples processed in these tubes were stored at room temperature for no longer than two days, testing has yielded reliable results. However, if samples were stored for more than two days, the blood alcohol determination might not be accurate, potentially resulting in falsely low or falsely high readings.
The product was distributed nationwide in the United States in the states of California, Florida, Georgia, Illinois, Kansas, Missouri, Pennsylvania, Rhode Island, and Tennessee, as well as in Canada. Users of these tubes should check their inventory for the specific lot number and expiration date listed above. If the product matches the recall criteria, it should be returned to the supplier or disposed of according to local regulations, and any pending or recent test results involving samples stored for more than two days should be reviewed for potential inaccuracy.
The recalled product
- Product
- BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 247,000
Distribution
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