FDA Recall
Terminated
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Recall: Z-0012-04
·
Initiated May 8, 2003
Recall
- Recall Number
- Z-0012-04
- Event Number
- 26231
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 8, 2003
- Posted
- October 15, 2003
- Terminated
- December 9, 2003
- Address
- 9115 Hague Road, Indianapolis, IN, 46250-0457
Description
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Reason
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
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.
Distribution
United States
Quantity
478