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

• Date Initiated by Firm: March 12, 2009
• Date Posted: September 18, 2009
• Recall Status: Terminated 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.
• FEI Number: 1217454
• 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: 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.