Sysmex Automated Blood Coagulation Analyzers (2020-09-10)
- Starting date:
- September 10, 2020
- Posting date:
- December 18, 2020
- 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-74595
Last updated: 2020-12-18
Affected Products
A. CA-540
B. CA-540
C. CA-560
D. CS-20001
E. CS-21001
F. CA-620
G. CA-660
H. CS-5100
I. CS-2500
Reason
The manufacturer of the Sysmex Automated Blood Coagulation Analyzers, Sysmex Corporation, has informed Siemens Healthcare Diagnostics about a potential risk of sample contamination by Emicizumab (trade name Hemlibra®) from a sample containing this drug to the next sample analyzed on one of the Sysmex Automated Blood Coagulation Analyzers.
Affected products
A. CA-540
Lot or serial number
All lots.
Model or catalog number
CA-1500
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
B. CA-540
Lot or serial number
All lots.
Model or catalog number
B4260-540
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
C. CA-560
Lot or serial number
All lots.
Model or catalog number
B4260-560
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
D. CS-20001
Lot or serial number
All lots.
Model or catalog number
10488584
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
E. CS-21001
Lot or serial number
All lots.
Model or catalog number
10488586
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
F. CA-620
Lot or serial number
All lots.
Model or catalog number
10712040
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
G. CA-660
Lot or serial number
All lots.
Model or catalog number
CA-620
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
H. CS-5100
Lot or serial number
All lots.
Model or catalog number
CS-5100
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
I. CS-2500
Lot or serial number
All lots.
Model or catalog number
CS-2500
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN