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Autodelfia Enhancement Solution (2013-10-21)
- Starting date:
- October 21, 2013
- Posting date:
- November 29, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36877
Recalled Products
Autodelfia Enhancement Solution
Reason
Four batches of enhancement solution have been identified to be defective. The defect is seen as a high samarium background in Autodelfia assays using Samarium labeled antibody as tracer.
Affected products
Autodelfia Enhancement Solution
Lot or serial number
624401
624706
625438
625642
Model or catalog number
B118-100
Companies
- Manufacturer
-
Wallac OY
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND