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Id-Papain
- Starting date:
- July 17, 2017
- Posting date:
- August 14, 2017
- 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-64168
Reason
DiaMed GmbH has noticed that some lots show a double population results when the auto-control is performed in papain one stage technique. A decrease of the enzymatic activity may not destroy the target antigens as expected.
Affected products
Id-Papain
Lot or serial number
- 06311021
- 06311961
- 06311971
- 06311991
Model or catalog number
005510
Companies
- Manufacturer
-
Diamed GMBH
Pra Rond 23
Cressier FR
1785
SWITZERLAND