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Sysmex E-Check (2015-01-28)
- Starting date:
- January 28, 2015
- Posting date:
- February 16, 2015
- 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-43723
Recalled Products
A) Sysmex E-Check
Reason
An error on the XT-1800I and XT-2000I assay sheet for the mean values for the level 3 (L3) control.
Affected products
A) Sysmex E-Check
Lot or serial number
4365
5002
Model or catalog number
201-6001-0
Companies
- Manufacturer
-
Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire
60069
Illinois
UNITED STATES