Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CEDIA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CEDIAsee related information
Date Initiated by FirmFebruary 10, 2006
Date PostedFebruary 28, 2006
Recall Status1 Terminated 3 on June 23, 2006
Recall NumberZ-0574-06
Recall Event ID 34590
510(K)NumberK912143 
Product Classification Fluorescence Polarization Immunoassay, Tobramycin - Product Code LFW
ProductRoche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
Code Information Lot 56292625; exp. 05/31/07.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		May have tobramycin over-recovery at the trough level.
FDA Determined
Cause 2		Other
ActionConsignees were notified via phone and faxed recall letter on or about 2/10/06.
Quantity in Commerce1806 kits
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LFW
-
-