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Elecsys FT4
- Starting date:
- October 18, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, Product Safety
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15901
Recalled Products
- Elecsys FT4
- Manufacturer
- Roche Diagnostics GMBH
Reason
During recent internal on-board stability studies, decreasing calibrator signals were observed for Elecsys FT4 reagent kits when stored more than 3 weeks on-board the Elecsys systems (Cobas E 411 and Cobas E 601/602)
Affected products
A. Elecsys FT4
Lot or serial number
16519303, 16519304, 16649801, 16649803
16763501, 16763502, 16763503, 16845401, 16845403
Model or catalog number
11731297122