Recall Z-0095-2023— Becton Dickinson & Company
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2022-09-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-15
- Firm location
- Franklin Lakes, NJ, United States
Product description
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.
Reason for recall
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.