BD Vacutainer Blood Alcohol Testing Tubes Recalled for Analytical Interference
BD Vacutainer blood collection tubes are recalled due to isobutylene contamination that may cause false positive results in blood alcohol testing.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. The hazard represents a risk of harm through analytical interference that may produce false positive test results, but no actual incidents have been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Sodium Fluoride/Potassium Oxalate tubes (Catalog Number 367001), used to collect, transport, and process blood samples for blood alcohol determination testing. Approximately 2.2 million units are affected, and all lots of the product are impacted.
The recalled tubes contain isobutylene, which interferes with gas chromatography methods used to measure methanol levels. This interference may lead to false positive results in blood alcohol testing.
The product has been distributed nationwide in the United States, as well as to Canada, New Zealand, and Hong Kong. Healthcare facilities and laboratories using these tubes for blood alcohol testing should be aware of this potential analytical interference.
The recalled product
- Product
- BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- analytical-interference
- false-positive-testing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: Case: 50382903670012
- Shelf: 30382903670018
- Each: 00382903670017
- ALL LOTS are affected.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighMedline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01