Device product
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.
Z-1320-2018
Product summary
- Event
- Event 79556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4838
- Official record key
device-enforcement:Z-1320-2018
Official wording
Reason: Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.
Code information: (1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112901, 2016060401, 2016052701, 2016052101, 2016050301; (2)105-005406-00 (20L container) Lot Numbers: 2017041104, 2016121901, 2016051801, 2016050301
Distribution pattern: US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Derived failure modes
-
Unknown
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.