Recall Z-2279-2019— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-05-30, terminated 2020-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations. Reason: Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high).
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-30
- Terminated
- 2020-05-05
- Firm location
- Franklin Lakes, NJ, United States
Product description
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Reason for recall
Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)
Data sourced from openFDA. This site is unofficial and independent of the FDA.