Device product

BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

Z-0061-2020

May 13, 2019

Class II

Product summary

Firm: Becton Dickinson & Company
Event: Event 82851
Status: Terminated
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-0061-2020

Official wording

Reason: 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.

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.