| Class 2 Device Recall CEDIA Tobramycin II Assay | |
Date Initiated by Firm | October 16, 2013 |
Date Posted | December 16, 2013 |
Recall Status1 |
Terminated 3 on February 03, 2014 |
Recall Number | Z-0513-2014 |
Recall Event ID |
66626 |
510(K)Number | K912143 |
Product Classification |
Fluorescence polarization immunoassay, tobramycin - Product Code LFW
|
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. |
Code Information |
Lot Number: 60169764 |
Recalling Firm/ Manufacturer |
Microgenics Corp 46360 Fremont Blvd Fremont CA 94538-6406
|
For Additional Information Contact | Mark H. Smith 510-979-5000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 370 units |
Distribution | Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = LFW
|
|
|
|