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 Clinitek

  • 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 Clinitek see related information
Date Initiated by Firm June 19, 2003
Date Posted June 21, 2003
Recall Status1 Terminated 3 on September 02, 2004
Recall Number Z-0911-03
Recall Event ID 26312
510(K)Number K960546  
Product Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]
Code Information serial numbers 168252 through 169574.
Recalling Firm/
Manufacturer		 Bayer HealthCare LLC, Diagnostics Div
1884 Miles Ave.
Elkhart IN 46515
For Additional Information Contact
877-229-3711
Manufacturer Reason
for Recall		 Analyzer will produce erroneous results due to missing grounding strap.
FDA Determined
Cause 2		 Other
Action Marketing sent a 'dear customer' letter to each account on May 13, 2003 telling them that their instrument had been identified as not meeting a production specification. An urgent product correction letter was subsequently sent to each account on or about June 20, 2003. The analyzers affected will be replaced.
Quantity in Commerce 1324
Distribution United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
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 = and Original Applicant = BAYER CORP.
-
-