Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Hazard
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
What You Should Do
Remedy
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.
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Products
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
- Brand
- Roche Diagnostics Corp.
- UPC
- All units with current software versions (v 06-06 and 07-01).
Units Affected
478