Device product
BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
Z-2279-2019
Product summary
- Event
- Event 83020
- Status
- Terminated
- Classification
- Class II
- Quantity
- 247,000 tubes
- Official record key
device-enforcement:Z-2279-2019
Official wording
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)
Code information: Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100
Distribution pattern: US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Derived failure modes
-
Unknown
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)