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FT4 II (FREE THYROXINE II) (2016-05-11)
- Starting date:
- May 11, 2016
- Posting date:
- May 24, 2016
- 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-58516
Affected products
- FT4 II (FREE THYROXINE II)
Reason
In the software screens on cobas e 602, the expiry date of FT4 II reagent kit lot 188609 could be displayed 11/2016, instead of the correct date 10/2016 which is the expiry date of the box and the reagent kit label. When this occurs, the false expiry date is used with the reagent kits.
Affected products
A. FT4 II (FREE THYROXINE II)
Lot or serial number
188609
Model or catalog number
6437281190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY