Z-1435-04

Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog...

Name: Z-1435-04 Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog...
Creator: Roche Diagnostics Corp.
Published: 2004-08-20
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-08-20 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216) on 2004-08-20. The reason FDA records is "Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1435-04
Status: Terminated
Initiated: 2004-08-20
Posted: 2004-09-02
Terminated: 2004-11-05
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
Product code: CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Reason for recall: Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
FDA root cause: Other
Action: Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.
Quantity in commerce: 757non-expired kits.
Distribution: Nationwide.
Product codes and lots: All lots expiring on or before 7/05.

Product code CIT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)