Becton Dickinson, the leading manufacturer of blood vials for DWI blood testing initiated a medical device recall for the BD Vacutainer Fluoride Tubes on June 12. The root cause was related to a manufacturing error. A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).
BD stated that a small portion of the vials had been confirmed to have no preservative nor anti-coagulant additive within the tube. According to BD, once blood is collected in the tubes, the clinician will be unable to determine if the tube contains an additive or not. The tubes are supposed to contain potassium oxalate (anticoagulant) and sodium fluoride a preservative to prevent fermentation and neo-production of Alcohol.
BD asserts that there is no worry or need for concern since blood samples processed without the additive can yield reliable results if the samples are stored at room temperature for no longer than two days.
This is wishful thinking. No police department in Central Texas tests blood within two days and the Austin Police Department now takes approximately ten months. Many police departments do not have protocols for storing blood and do a sloppy job of documenting when and how the blood was stored after collection.
Significantly, BD admits that if the sample is stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high). BD’s authority for this claim can be found at BD’s website: BD Statement on Voluntary Recall of BD Vacutainer® Fluoride Tubes for Blood Alcohol Determinations, Jun 21, 2019, citing to Wu, A. H. (2006), Tietz clinical guide to laboratory tests. St. Louis, MO: Saunders/Elsevier. Section IV- Therapeutic Drugs and Drugs of Abuse p. 1345.
The Houston Chronicle reported: “The recall by the vial manufacturer could jeopardize drunken-driving cases nationwide, and at least 7,800 local cases have been identified with blood evidence that could have used vials named in the recall, officials said.”
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