Z-0513-2014 Class II Terminated
FDA device recall Z-0513-2014 was initiated by Microgenics Corp on October 16, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated February 3, 2014). Affected quantity: 370 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- October 16, 2013
- Termination Date
- February 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 370 units
Product 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 for Recall
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.
Distribution Pattern
Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Code Information
Lot Number: 60169764