Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay — Class II medical device recall Z-0513-2014
Terminated recall by Microgenics Corp, reported 2013-12-25, distributed in CA, MT, ND, OK, UT, WA, WI. Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169
| Recall number | Z-0513-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corp, Fremont, CA, United States |
| Recall initiated | 2013-10-16 |
| Classified | 2013-12-16 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-02-03 |
| Distributed | CA, MT, ND, OK, UT, WA, WI |
| Countries outside the US | AU, CA, DE |
| Quantity | 370 units |
| Reason classes | potency, specification failure |
| Lot numbers | 60169764 |
| Model numbers | 100018 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0513-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.