Z-2223-2009

BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and...

Name: Z-2223-2009 BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and...
Creator: BioTek Instruments, Inc.
Published: 2009-03-12
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2009-03-12 / Terminated / root cause: software

FDA source

BioTek Instruments, Inc. began a recall of BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed... on 2009-03-12. The reason FDA records is "Software design allowed false negatives to be read when wells are dark". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2223-2009
Status: Terminated
Initiated: 2009-03-12
Posted: 2009-09-18
Terminated: 2015-05-18
Recalling firm: Agilent Technologies, Inc.
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.
Product code: JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall: Software design allowed false negatives to be read when wells are dark.
Root cause tag: software
FDA root 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.
Product codes and lots: Software versions 1.07 and lower.

Product code JJQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)