Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
FDA Recall Z-0012-04 · Posted 2003-10-15
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2003-05-08
Date Terminated2003-12-09
Product Quantity478
Reason for Recall
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
Firm 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.
Root Cause
Other
Distribution Pattern
United States
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.