BioTek Instruments, Inc. Highland Park/Box 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
BioTek Instruments, Inc. Highland Park/Box
Lot Codes / Batch Numbers
Software versions 1.07 and lower.
Products Sold
Software versions 1.07 and lower.
BioTek Instruments, Inc. Highland Park/Box is recalling BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with due to Software design allowed false negatives to be read when wells are dark.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software design allowed false negatives to be read when wells are dark.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026