Devices

Device Recall M30 D Diluent

Model / Serial
(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
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Product Description
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.
Manufacturer
Mindray DS USA, Inc. dba Mindray North America
1 Event
- Recall of Device Recall M30 D Diluent

Manufacturer

Mindray DS USA, Inc. dba Mindray North America

Manufacturer Address
Mindray DS USA, Inc. dba Mindray North America, 800 Macarthur Blvd, Mahwah NJ 07430-2001
Manufacturer Parent Company (2017)
Shenzhen Mindray Bio-Medical Electronics Co. Ltd.
Source
USFDA

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