Device product
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
Z-0059-2020
Product summary
- Event
- Event 82851
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0059-2020
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: 808592N (01)30382903659853 (17)190630(10)808592N(30)50 (17)190630(10)808592N(30)200(01)50382903659857 809669N (01)30382903659853 (17)190630(10)809669N(30)50 (17)190630(10)809669N(30)200(01)50382903659857 811070N (01)30382903659853 (17)190630(10)811070N(30)50 (17)190630(10)811070N(30)200(01)50382903659857 811071N (01)30382903659853 (17)190630(10)811071N(30)50 (17)190630(10)811071N(30)200(01)50382903659857 811664N (01)30382903659853 (17)190630(10)811664N(30)50 (17)190630(10)811664N(30)200(01)50382903659857 813767N (01)30382903659853 (17)190731(10)813767N(30)50 (17)190731(10)813767N(30)200(01)50382903659857 815060N (01)30382903659853 (17)190731(10)815060N(30)50 (17)190731(10)815060N(30)200(01)50382903659857 815061N (01)30382903659853 (17)190831(10)815061N(30)50 (17)190831(10)815061N(30)200(01)50382903659857 815062N (01)30382903659853 (17)190831(10)815062N(30)50 (17)190831(10)815062N(30)200(01)50382903659857 816499N (01)30382903659853 (17)190831(10)816499N(30)50 (17)190831(10)816499N(30)200(01)50382903659857 821563N (01)30382903659853 (17)191031(10)821563N(30)50 (17)191031(10)821563N(30)200(01)50382903659857 821564N (01)30382903659853 (17)191031(10)821564N(30)50 (17)191031(10)821564N(30)200(01)50382903659857 821565N (01)30382903659853 (17)191031(10)821565N(30)50 (17)191031(10)821565N(30)200(01)50382903659857 821888N (01)30382903659853 (17)191031(10)821888N(30)50 (17)191031(10)821888N(30)200(01)50382903659857 827063N (01)30382903659853 (17)191231(10)827063N(30)50 (17)191231(10)827063N(30)200(01)50382903659857 827064N (01)30382903659853 (17)191231(10)827064N(30)50 (17)191231(10)827064N(30)200(01)50382903659857 827589N (01)30382903659853 (17)191231(10)827589N(30)50 (17)191231(10)827589N(30)200(01)50382903659857 827693N (01)30382903659853 (17)191231(10)827693N(30)50 (17)191231(10)827693N(30)200(01)50382903659857 827699N (01)30382903659853 (17)191231(10)827699N(30)50 (17)191231(10)827699N(30)200(01)50382903659857"
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.