Devices

Device Recall M53D Diluent

Model / Serial
Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302
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-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) || The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
Manufacturer
Mindray DS USA, Inc. dba Mindray North America
1 Event
- Recall of Device Recall M53D 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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