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REMEL PATHODX STREP GROUP B LATEX (2015-05-01)
- Starting date:
- May 1, 2015
- Posting date:
- June 26, 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-53918
Recalled Product
A.REMEL PATHODX STREP GROUP B LATEX
Reason
A technical investigation has confirmed that PathoDX Strep B Latex may produce weak or slow reactions that may result in a failure to identify b-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
Affected products
A.REMEL PATHODX STREP GROUP B LATEX
Lot or serial number
LOT 1463129
LOT 1470133
Model or catalog number
R62025
R62031
Companies
- Manufacturer
-
Oxoid Limited
Wade Road
Basingstoke, Hampshire
RG24 8PW
UNITED KINGDOM