X-CAL, Sysmex E-Check, 8Check 3WP X-TRA Control, Sysmex SCS-1000 Universal Calibrator, XN CHECK, XN CAL, XN CAL PF, XN CAL - CUSTOMER SET, XN CAL PF - CUSTOMER SET, and XN-L CHECK (2018-05-08)
- Starting date:
- May 8, 2018
- Posting date:
- August 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67374
Affected products
- X-CAL
- Sysmex E-Check
- 8Check 3WP X-TRA Control
- Sysmex SCS-1000 Universal Calibrator
- XN Check
- XN CAL
- XN CAL PF
- XN CAL - CUSTOMER SET
- XN CAL PF - CUSTOMER SET
- XN-L CHECK
Reason
Sysmex America, Inc. received and increased number of complaints for low recovery or imprecision of Platelet (PLT) counts and associated parameters including Mean Platelet Volume (MPV), and Immature Platelet Fraction (IPF) with hematology controls and calibrators. Remixing the product and repeating analysis gave acceptable results. No product defect was identified; however, mixing the product per the package insert instructions was insufficient to ensure consistent PLT recovery within the assay sheet ranges.
Affected products
A. X-CAL
Lot or serial number
beginning with 7283
Model or catalog number
- 110-4008-0
- 110-4009-0
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
B. Sysmex E-Check
Lot or serial number
beginning with 7269
beginning with 7277
beginning with 7305
Model or catalog number
199-4004-1
199-5001-0
199-5002-0
201-6001-0
201-6002-0
201-6003-0
201-6004-0
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
C. 8Check 3WP X-TRA Control
Lot or serial number
beginning with 7255
Model or catalog number
14030040
14030060
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
D. Sysmex SCS-1000 Universal Calibrator
Lot or serial number
beginning with 7283
Model or catalog number
160-4002-0
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
E. XN Check
Lot or serial number
beginning with 7261
Model or catalog number
213499
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
F. XN CAL
Lot or serial number
beginning with 7282
Model or catalog number
XN CAL
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
G. XN CAL PF
Lot or serial number
beginning with 7282
Model or catalog number
XN CAL PF
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
H. XN CAL - CUSTOMER SET
Lot or serial number
beginning with 7283
Model or catalog number
213527
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
I. XN CAL PF - CUSTOMER SET
Lot or serial number
beginning with 7282
Model or catalog number
213536
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
J. XN-L CHECK
Lot or serial number
beginning 7300
Model or catalog number
213569
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN