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HER2 CISH PHARMDX KIT (2016-06-10)
- Starting date:
- June 10, 2016
- Posting date:
- July 7, 2016
- 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-59238
Affected products
A. HER2 CISH PHARMDX KIT
Reason
A wrong titration method was used when producing the probe mix for SK109 vial 3. This has resulted in the HER2 DNA Probe concentration being approximately 4-5 times lower than usual for this product.
Affected products
A. HER2 CISH PHARMDX KIT
Lot or serial number
20031665
Model or catalog number
SK109
Companies
- Manufacturer
-
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK