Recall Z-0513-2014 ยท LFW Fluorescence Polarization Immunoassay, Tobramycin
Microgenics Corp
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.
| Date | Dec 16, 2013 (initiated Oct 16, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact mgc@thermofisher.com. For question regarding this recall call 1-800-232-3342. |
| Quantity | 370 units |
| Distribution | Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912143 | CEDIA(R) TOBRAMYCIN ASSAY Microgenics Corp., Jul 26, 1991 |