Company:BioTek Instruments, Inc.
Date of Enforcement Report 12/30/2009
Class:ll
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. Recall # Z-2223-2009
REASON
Software design allowed false negatives to be read when wells are dark.
RECALLING FIRM/MANUFACTURER
BioTek Instruments, Inc., Winooski, VT, by letters dated March 13, 2009 and March 25, 2009. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX and Peru
