Z-0028-04

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal...

Name: Z-0028-04 Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal...
Creator: Roche Diagnostics Corp.
Published: 2003-09-02
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-09-02 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837 on 2003-09-02. The reason FDA records is "Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0028-04
Status: Terminated
Initiated: 2003-09-02
Posted: 2003-10-15
Terminated: 2003-12-10
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
Product code: LNN
Reason for recall: Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
FDA root cause: Other
Action: Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
Quantity in commerce: 21958
Distribution: United States, Canada and Germany
Product codes and lots: All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.

Product code LNN

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)