An announcement from Becton Dickinson and Company (BD) may raise doubts about the validity of some blood alcohol tests conducted across the country since August 31, 2018.
On May 30, 2019, with a correction made June 12, 2019, BD announced a recall for its “BD Vacutainer® Fluoride Tubes for Blood Alcohol Determinations” product. Vacutainers are blood collection tubes with a colored stopper and specific additives to stabilize and preserve the specimen for testing purposes. BD reports that a now-corrected manufacturing error caused around 100 vials from a batch of around 240,000 to be manufactured and distributed without an additive needed to prevent coagulation and preserve the sample. Vacutainers without the additive might yield a “falsely high” blood alcohol measurement.
The affected lot of vacutainers was distributed beginning on August 31, 2018. According to BD, the absence of the additive powder can be detected by a diligent blood collection technician, but after blood is drawn into the vacutainer the technician will not be able to tell whether the additive is present. While the number of affected vacutainers is ultimately an incredibly small proportion of the total number of vacutainers distributed, the impact of a false blood alcohol reading can be significant for an individual. Attorneys involved in cases with blood alcohol analysis should be aware of the potential for affected results and seek to find out if the vacutainers used in their case came from the recalled lot.
Several forensic science groups in Texas have released statements recognizing the seriousness of this mistake. The potential for compromised test results has been publicized by the Houston Forensic Science Center (HFSC) in a memo, which states that sharing the information was necessary “…to ensure prosecutors, defendants and all others in the justice system have the information needed to move forward.” The Texas Forensic Science Commission also issued a memo stating that “it is not feasible to determine whether the additive powders (preservative, anticoagulant, or both) were present after blood was introduced into the tube.” The memo goes on to state “[i]t is also possible for a tube without additive to lack any visual indication of blood clotting.”
In an effort to assist attorneys involved in any cases where an affected BD vacutainer may have been used, we have compiled a few resources below. First, this document is designed to assist attorneys attempting to find out if the vacutainer involved in their client’s case is part of the faulty batch. Second, this draft motion to exclude expert testimony presents an argument where a grey-topped tube is not accompanied by lot-identifying information (because it is covered by the seal or it was not recorded in any reports). A document with useful images is available here. It may ultimately be necessary for attorneys to physically examine their client’s vacutainer, and even then it might be difficult to determine if the blood analysis could have been affected.
We have communicated with the NC State Crime Laboratory about this issue, though the Crime Lab is not the only lab which would perform blood alcohol analysis in our state. The Crime Lab indicated that law enforcement agencies are aware of the issue and are checking blood alcohol collection kits before using them to ensure the vacutainers are not in the affected lot. The Crime Lab said that any visible coagulation would be noted in the case file. Coagulation may indicate a vacutainer lacked the necessary additives. The Crime Lab also noted that one manufacturer that assembles the blood collection kits for NC has said they would reject any vacutainers that were observed to be lacking the additives. If your case involves the NC State Crime Laboratory, Assistant Attorney General Jason Caccamo or Toxicology Forensic Science Manager Aaron Joncich are available to discuss steps that the Crime Lab has implemented since receiving notice of the recall.