FDA Enforcement
Class II
Terminated
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.
Recall: Z-0513-2014
·
Reported December 25, 2013
Enforcement
- Recall Number
- Z-0513-2014
- Event ID
- 66626
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Microgenics Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2013
- Initiation Date
- October 16, 2013
- Classification Date
- December 16, 2013
- Termination Date
- February 3, 2014
- Address
- 46360 Fremont Blvd, N/A, Fremont, CA, 94538-6406, United States
Description
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.
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 Info
Lot Number: 60169764
Distribution
Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Quantity
370 units