Z-0899-06

Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542...

Name: Z-0899-06 Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542...
Creator: Roche Diagnostics Corp.
Published: 2006-04-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-04-12 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic on 2006-04-12. The reason FDA records is "A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0899-06
Status: Terminated
Initiated: 2006-04-12
Posted: 2006-05-25
Terminated: 2006-10-16
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
Product code: CFR Hexokinase, Glucose
Reason for recall: A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
FDA root cause: Other
Action: A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.
Quantity in commerce: 269 kits
Distribution: Nationwide.
Product codes and lots: Lot 672652; exp. 6/30/2007.

Product code CFR

K854025Class IHitachi 704Boehringer Mannheim Corp. / cleared 1985-10-28

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)