Device product
BD Microtainer SST- Amber Part/Catalog Number: 365978
Z-0058-2020
Product summary
- Event
- Event 82851
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0058-2020
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: 8193502 (01)30382903659785 (17)190930(10)8193502(30)50 (17)190930(10)8193502(30)200(01)50382903659789 8193507 (01)30382903659785 (17)190930(10)8193507(30)50 (17)190930(10)8193507(30)200(01)50382903659789 8193511 (01)30382903659785 (17)190930(10)8193511(30)50 (17)190930(10)8193511(30)200(01)50382903659789 8204927 (01)30382903659785 (17)190930(10)8204927(30)50 (17)190930(10)8204927(30)200(01)50382903659789 8205758 (01)30382903659785 (17)190930(10)8205758(30)50 (17)190930(10)8205758(30)200(01)50382903659789 8207774 (01)30382903659785 (17)190930(10)8207774(30)50 (17)190930(10)8207774(30)200(01)50382903659789 8208542 (01)30382903659785 (17)190930(10)8208542(30)50 (17)190930(10)8208542(30)200(01)50382903659789 8208544 (01)30382903659785 (17)190930(10)8208544(30)50 (17)190930(10)8208544(30)200(01)50382903659789 8232513 "(01)30382903659785 (17)191031(10)8232513(30)50 (17)191031(10)8232513(30)200(01)50382903659789 8233967 (01)30382903659785 (17)191031(10)8233967(30)50 (17)191031(10)8236756(30)200(01)50382903659789 8236755 (01)30382903659785 (17)191031(10)8236755(30)50 (17)191031(10)8236755(30)200(01)50382903659789 8236756 (01)30382903659785 (17)191031(10)8236756(30)50 (17)191031(10)8233967(30)200(01)50382903659789 8239857 (01)30382903659785 (17)191031(10)8239857(30)50 (17)191031(10)8239857(30)200(01)50382903659789 8260948 (01)30382903659785 (17)191130(10)8260948(30)50 (17)191130(10)8260948(30)200(01)50382903659789 8262866 (01)30382903659785 (17)191130(10)8262866(30)50 (17)191130(10)8262866(30)200(01)50382903659789 8282812 (01)30382903659792 (17)191231(10)8282812(30)50 (17)191231(10)8282812(30)200(01)50382903659796"
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.