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U.S. Department of Health and Human Services

Class 2 Device Recall BioTek Gen5CL Microplate Data Collection and Analysis Software

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 Class 2 Recall
BioTek Gen5CL Microplate Data Collection and Analysis Software
see related information
Date Posted September 18, 2009
Recall Status1 Open
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, Vermont 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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