Z-0061-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- May 13, 2019
- Termination Date
- August 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
Reason for Recall
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Distribution Pattern
Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Code Information
Lot Number/UDI: 8212777 (01)30382903659921 (17)191031(10)8212777(30)50 (17)191031(10)8212777(30)200(01)50382903659925 8212785 (01)30382903659921 (17)191031(10)8212785(30)50 (17)191031(10)8212785(30)200(01)50382903659925 8268546 (01)30382903659921 (17)191130(10)8268546(30)50 (17)191031(10)8268546(30)200(01)50382903659925 8268549 "(01)30382903659921 (17)191130(10)8268549(30)50 (17)191130(10)8268549(30)200(01)50382903659925