Roche Diagnostics Corp.
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
| Date | Oct 15, 2003 (initiated May 8, 2003) |
| Status | Terminated |
| Reason | Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted. |
| Root cause | Other |
| Action | Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied. |
| Quantity | 478 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER Boehringer Mannheim Corp., Sep 25, 1995 |