Z-2279-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2019
- Initiation Date
- May 30, 2019
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 247,000 tubes
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)
Distribution Pattern
US Nationwide-Distribution in the states of CA, FL, GA, IL, KS, MO, PA, RI, TN Foreign: Canada
Code Information
Lot Number: 8187663 Exp. Date: 2020/7/31 UDI: (01)30382903670018 (17)200731(10)8187663 (30)0100