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Salmonella Agglutinating Serum O poly A-S (2016-06-10)
- Starting date:
- June 10, 2016
- Posting date:
- June 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-59034
Affected products
A. Salmonella Agglutinating Serum O poly A-S
Reason
The overall performance of the antisera has deteriorated and this is more marked in some factors than others. The product was deemed not fit for purpose as it had deteriorated since being put on the market. It was still agglutinating with most salmonella cultures tested against, but was slower against some of the higher somatics, as it is not detecting within one minute which is stated in the instructions for use.
Affected products
A. Salmonella Agglutinating Serum O poly A-S
Lot or serial number
1335
Model or catalog number
PL 6002
Companies
- Manufacturer
-
Pro-Lab Diagnostics
3 Bassendale Road
Bromborough, Merseyside
CH62 3QL
UNITED KINGDOM