CELLSEARCH Circulating Tumor Cell Kit (2018-04-03)
- Starting date:
- April 3, 2018
- Posting date:
- January 8, 2019
- 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-68698
Affected products
CELLSEARCH Circulating Tumor Cell Kit
Reason
A thorough review of the manufacturing work instructions and batch records identified an error in the staining reagent manufacturing SOP used by the contract manufacturer.
Affected products
CELLSEARCH Circulating Tumor Cell Kit
Lot or serial number
- S038R
Model or catalog number
- 7900001
Companies
- Manufacturer
-
Menarini Silicon Biosystems, Inc.
3401 Masons Mill Rd, Suite 100
Huntingdon Valley, Pennsylvania
19006
Pennsylvania
UNITED STATES