Recall Z-2223-2009 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
BioTek Instruments, Inc.
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.
| Date | Sep 18, 2009 (initiated Mar 12, 2009) |
| Status | Terminated |
| Reason | Software design allowed false negatives to be read when wells are dark. |
| 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 | 13 |
| Distribution | Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.