30
Dec
2009

Cl Il BioTek Gen5CL Microplate Software

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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