Health product recall

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