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BIOPHEN ARIXTRA CONTROL PLASMA (2017-09-01)
- Starting date:
- September 1, 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-64588
Affected products
BIOPHEN ARIXTRA CONTROL PLASMA
Reason
This is a correction. Typographical error on the flyer included with the product. C1 acceptance range incorrectly printed as 0.3 - 0.56 microgramme/ml. The correct C1 acceptance range is 0.36 - 0.56 microgramme/mL.
Affected products
BIOPHEN ARIXTRA CONTROL PLASMA
Lot or serial number
F1600528
Model or catalog number
224001
Companies
- Manufacturer
-
HYPHEN BIOMED
155 RUE D' ERAGNY, NEUVILLE SUR OISE
95000
FRANCE