Device product
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.
Z-0513-2014
Product summary
- Firm
- Microgenics Corp
- Event
- Event 66626
- Status
- Terminated
- Classification
- Class II
- Quantity
- 370 units
- Official record key
device-enforcement:Z-0513-2014
Official wording
Reason: Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
Code information: Lot Number: 60169764
Distribution pattern: Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Derived failure modes
-
Unknown
Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.