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

  • 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 see related information
Date Initiated by Firm May 26, 2005
Date Posted July 16, 2005
Recall Status1 Terminated 3 on June 12, 2006
Recall Number Z-1016-05
Recall Event ID 32303
510(K)Number K980283  
Product Classification Enzyme Immunoassay, Carbamazepine - Product Code KLT
Product Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
Code Information Generations 18, 19, 20, 21, and 23
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Judy M. Strzepek
908-218-8524
Manufacturer Reason
for Recall		 Falsely elevated Carbamazepine results.
FDA Determined
Cause 2		 Other
Action Letters dated 5/26/05 with instructions to discontinue use and discard slides. Customers also instructed to review previous results with Laboratory Medical Director to determine need for further consultation with health care provider.
Quantity in Commerce 5,846 boxes
Distribution 423 U.S. consignees nationwide, and 22 OCD/J&J foreign affiliates (Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain)
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 = KLT and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
-
-