FDA Device recall Z-0513-2014
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Mic…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Mic… by Microgenics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0513-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-16 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microgenics |
| Distribution | CA, MT, ND, OK, UT, WA, WI |
Product
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.
Identifiers
| code_info | Lot Number: 60169764 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2014%22
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