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8Check 3WP X-TRA Control (2017-08-31)
- Starting date:
- August 31, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64568
Affected products
8Check 3WP X-TRA Control
Reason
Correction is for the EightCheck 3WP X-TRA Hematology control package insert. This correction alerts the customers to inadvertent changes to the package insert that impact mixing instructions and recommendations about acceptable targets and limits of control performance.
Affected products
8Check 3WP X-TRA Control
Lot or serial number
- 7087
- 7088
- 7171
- 7172
Model or catalog number
- 14030040
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN