Device product
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
Z-0060-2020
Product summary
- Event
- Event 82851
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0060-2020
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: 819352N (01)30382903659877 (17)190930(10)819352N(30)50 (17)190930(10)819352N(30)200(01)50382903659871 822851N (01)30382903659877 (17)191031(10)822851N(30)50 (17)191031(10)822851N(30)200(01)50382903659871 822852N (01)30382903659877 (17)191031(10)822852N(30)50 (17)191031(10)822852N(30)200(01)50382903659871 822853N (01)30382903659877 (17)191031(10)822853N(30)50 (17)191031(10)822853N(30)200(01)50382903659871 822854N (01)30382903659877 (17)191031(10)822854N(30)50 (17)191031(10)822854N(30)200(01)50382903659871 822855N (01)30382903659877 (17)191031(10)822855N(30)50 (17)191031(10)822855N(30)200(01)50382903659871 822862N (01)30382903659877 (17)191031(10)822862N(30)50 (17)191031(10)822862N(30)200(01)50382903659871 824092N (01)30382903659877 (17)191031(10)824092N(30)50 (17)191031(10)824092N(30)200(01)50382903659871 826768N (01)30382903659877 (17)191130(10)826768N(30)50 (17)191130(10)826768N(30)200(01)50382903659871 827652N (01)30382903659877 (17)191231(10)827652N(30)50 (17)191231(10)827652N(30)200(01)50382903659871 827753N (01)30382903659877 (17)191231(10)827753N(30)50 (17)191231(10)827753N(30)200(01)50382903659871 827754N (01)30382903659877 (17)191231(10)827754N(30)50 (17)191231(10)827754N(30)200(01)50382903659871
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
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.