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XN CHECK (2016-03-30)
- Starting date:
- March 30, 2016
- Posting date:
- April 15, 2016
- 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-57934
Affected products
A. XN CHECK
Reason
Sysmex America Inc. has become aware that the IPF% level 2 expected range was incorrectly reported for XN check lot numbers 6067 and 6068. The IPF% level 2 mean values are correct. Applicable instruments are XN-series (XN-10, XN-20, XN-11, XN-21) analyzers. Assay sheets have been amended with the correct IPF% level 2 expected ranges. All other parameter means and expected ranges are correct. Use of the original assay sheet may falsely indicate that the control is recovering outside of the true expected range.
Affected products
A. XN CHECK
Lot or serial number
6067
6068
Model or catalog number
213499
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN