Z-0736-2007

Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800...

Name: Z-0736-2007 Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800...
Creator: Roche Diagnostics Corp.
Published: 2007-03-16
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-03-16 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog... on 2007-03-16. The reason FDA records is "The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0736-2007
Status: Terminated
Initiated: 2007-03-16
Posted: 2007-04-13
Terminated: 2008-06-12
Recalling firm: Roche Diagnostics GmbH
Product: Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
Product code: KXT Enzyme Immunoassay, Digoxin
Reason for recall: The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this issue, the Digoxin LDL claim has been revised to 0.3 ng/mL for all reagent lots.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.
Quantity in commerce: 4,735
Distribution: Nationwide.
Product codes and lots: All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)

Product code KXT

K851032Class IICobas Fp Reagents for Digoxin & Cobas Fp Digoxin CRoche Diagnostic Systems, Inc. / cleared 1985-04-03

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)