FDAFDA · Food and drugs·Recall number Z-0513-2014
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.
Published December 25, 2013 · Recall initiated: October 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microgenics Corp
- Distributor
- Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
- Lot
- Lot Number: 60169764
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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