Roche Diagnostics Corp.
COBAS INTEGRA Creatinine Jaffe for use on the INTEGRA 400, 700 and 800 analyzers; system ID # 0764345, catalog # 20764345
| Date | Mar 21, 2003 (initiated Feb 13, 2003) |
| Status | Terminated |
| Reason | After a cassette change, patient results and controls may be up to 40% too low or too high due to calibration factor variation. |
| Root cause | Other |
| Action | An urgent product removal bulletin dated 2/14/03 was sent to each affected customer advising them to discontinue use of this lot, to discard any product on hand, and to contact Roche for replacement. |
| Quantity | 1905 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951595 | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES Roche Diagnostic Systems, Inc., Sep 8, 1995 |