Recall Z-1044-03 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corp.
MagNA Pure LC Instrument; Catalog number 2236931.
| Date | Jul 23, 2003 (initiated Jun 26, 2003) |
| Status | Terminated |
| Reason | A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols. |
| Root cause | Other |
| Action | An urgent product correction letter dated 6/26/03 was sent to each customer advising them not to use DNA protocols until the software update has been installed. |
| Quantity | 17 |
| Distribution | Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.