Z-0012-04

Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156

Name: Z-0012-04 Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156
Creator: Roche Diagnostics Corp.
Published: 2003-05-08
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-05-08 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156 on 2003-05-08. The reason FDA records is "Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0012-04
Status: Terminated
Initiated: 2003-05-08
Posted: 2003-10-15
Terminated: 2003-12-09
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
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.
FDA 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 in commerce: 478
Distribution: United States
Product codes and lots: All units with current software versions (v 06-06 and 07-01).

K953239Class IBoehringer Mannheim/hitachi 917 AnalyzerBoehringer Mannheim Corp. / cleared 1995-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)