Recall Z-0573-05 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Roche Diagnostics Corp.
BioTek brand Automated Microplate Reader; model ELx800, Roche catalog number 21045059001.
| Date | Mar 8, 2005 (initiated Feb 15, 2005) |
| Status | Terminated |
| Reason | The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives. |
| Root cause | Other |
| Action | Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS Bio-Tek Instruments, Inc., Mar 21, 1995 |