Z-0513-2014Class II

Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is...

Name: Z-0513-2014 Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is...
Creator: Microgenics Corp
Published: 2013-10-16
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2013-10-16 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corp began a recall of Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics... on 2013-10-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0513-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-16
Posted: 2013-12-16
Terminated: 2014-02-03
Recalling firm: Microgenics Corporation
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.
Product code: LFW Fluorescence Polarization Immunoassay, Tobramycin
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. For question regarding this recall call 1-800-232-3342.
Quantity in commerce: 370 units
Distribution: Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Product codes and lots: Lot Number: 60169764

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0513-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-16

Product code LFW

K912143Class IICedia(r) Tobramycin AssayMicrogenics Corp. / cleared 1991-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)