Device product

BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

Z-0055-2020

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-0055-2020

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: 811767N (01)30382903659655 (17)190930(10)811767N(30)50 (17)190930(10)811767N(30)200 (01)50382903659659 2019-09-30 815066N (01)30382903659655 (17)191130(10)815066N(30)50 (17)191130(10)815066N(30)200 (01)50382903659659 821471N (01)30382903659655 (17)200131(10)821471N(30)50 (17)200131(10)821471N(30)200 (01)50382903659659 821990N (01)30382903659655 (17)200131(10)821990N(30)50 (17)200131(10)821990N(30)200 (01)50382903659659

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.