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Earlier in June, the Minnesota Bureau of Criminal Apprehension (BCA) issued a significant recall of blood alcohol testing kits provided by manufacturer Becton Dickinson (BD) causing speculation over whether thousands of DWI cases will subsequently be thrown out in court. In fact, BD initially issued the voluntary recall.

The recall centered around potentially faulty vials which did not contain the requisite preservatives inside them to prevent sample clotting and fermentation. Said chemical preservatives are the primary safeguard for accurate blood alcohol testing because should fermentation, and subsequent clotting, occur, then the sample is rendered completely unusable in a court of law.

The science behind the recall

The potential problem has nothing to do with the inorganic salts inside the tube because these compounds perpetually remain stable. With respect to the tubes central to the recall—BD Vaccutainers—the potential problem is tied directly to the vacuum seal on the septa. Thus—as is the case with both tubes with expired warranty dates and faulty tubes such as those under recall—the vacuum pressure is compromised and, ultimately, subjects the sample to degeneration by pressure leakage or the potential for contaminants to enter the tube.

Unless lab clinicians possess the requisite training, education, and credentials, they will not be able to ascertain whether the tubes are faulty or not and, therefore, whether the sample taken is accurate.

BCA response

Even though BD claimed that the recall was directed at only around 300 vials—and that 200 of them had already been recalled—the state BCA is still rightly concerned about the potential impact of this recall on DWI cases.

Granted, quality control is not solely the manufacturer’s responsibility as the BCA should also be spot checking the BAC testing kits as well.

The BCA issued a statement that said that, in fact, BAC test tubes are inspected upon arrival and they hadn’t received any that were obviously coagulated and, therefore, easily identifiable as defective. However, BD—in its recall—stated that once blood was collected in the test tube, it would be virtually impossible to determine if the tube contained the necessary additive and was or was not faulty at the outset. This begs the question of how would BCA be able to visually inspect a tube and identify whether it is defective or not if the manufacturer says that it’s virtually impossible to do so?

The bottom line

The end result could mean that tests taken between August 2018 and June 2019 could, effectively, be inaccurate. The problem is compounded when one takes into consideration defendants who have already pleaded guilty and had their driver’s licenses revoked based on the potentially inaccurate results from the kits given the inability for investigators or clinicians to scientifically determine whether the samples were or were not compromised.