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.
FDA Recall Z-2223-2009 · Posted 2009-09-18
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Recalling FirmBioTek Instruments, Inc.
Recall StatusTerminated
Product CodeJJQ
Date Initiated2009-03-12
Date Terminated2015-05-18
Product Quantity13
Reason for Recall
Software design allowed false negatives to be read when wells are dark.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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