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CellPack DST (2014-07-14)
- Starting date:
- July 14, 2014
- Posting date:
- October 29, 2014
- 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-41921
Recalled Products
CellPack DST
Reason
Inaccurate product labelling on reagent. The expiration date on the label states that it is to be used within 30 days of opening but the in reality it is acceptable for use within 60 days of opening. No claim of performance issue or harm to patients has occurred.
Affected products
CellPack DST
Lot or serial number
Y3001, Y3002, Y3003
Y4001, Y4002, Y4003
Model or catalog number
DST-300A
Companies
- Manufacturer
-
Sysmex Reagents America,
Two Nelson C White Parkway
Mundelein
60060
Illinois
UNITED STATES