BC-3200 and BC-3600 Auto Hematology Analyzer - Diluent M-30D (2018-02-28)
- Starting date:
- February 28, 2018
- Posting date:
- March 23, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66260
Affected products
A. BC-3200 Auto Hematology Analyzer - Diluent M-30D
B. BC-3600 Auto Hematology Analyzer- M-30D Diluent
Reason
There is a potential issue with the M-30D Diluent used with the BC-3200 and BC-3600 hematology analyzers. Use of the affected diluent may cause the system to produce an elevated platelet (PLT) background count.
Affected products
A. BC-3200 Auto Hematology Analyzer - Diluent M-30D
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
105-005405-00
105-005406-00
Companies
- Manufacturer
-
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Suite 3B, Keji 12th Road South, Hi-Tech Industrial Park
Nanshan, Guangdong
518057
CHINA
B. BC-3600 Auto Hematology Analyzer- M-30D Diluent
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
105-005405-00
105-005406-00
Companies
- Manufacturer
-
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Building, Suite 3B, Keji 12th Road South, Hi-Tech Industrial Park
Nanshan, Guangdong
518057
CHINA