Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay Recalled by Microgenics Corp Due to Microgenics Corp., part of Thermo Fisher Scientific, is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Microgenics Corp directly.
Affected Products
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.
Quantity: 370 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 7 states: CA, MT, ND, OK, UT, WA, WI
About Microgenics Corp
Microgenics Corp has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report