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 BioTek Gen5CL Microplate Data Collection and Analysis Software

  • 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 BioTek Gen5CL Microplate Data Collection and Analysis Software see related information
Date Initiated by Firm March 12, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on May 18, 2015
Recall Number Z-2223-2009
Recall Event ID 52218
Product Classification Colorimeter, photometer, spectrophotometer for clinical use - Product Code JJQ
Product BioTek Gen5CL Microplate Data Collection and Analysis Software.

Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.
Code Information Software versions 1.07 and lower.
Recalling Firm/
Manufacturer		 BioTek Instruments, Inc.
Highland Park/Box 998
Winooski VT 05404
For Additional Information Contact Lenore Buehrer
802-655-4040
Manufacturer Reason
for Recall		 Software design allowed false negatives to be read when wells are dark.
FDA Determined
Cause 2		 Software design
Action BioTek Instruments, Inc. issued a "Product Recall Notification" dated March 13, 2009 information customers of the affected product. Follow-up letters with software installation instructions were sent March 25, 2009. For further information, contact BioTek Instruments, Inc. at 1-888-451-5171 extension 405.
Quantity in Commerce 13
Distribution Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.
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.
-
-