Z-0977-2007

Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010...

Name: Z-0977-2007 Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010...
Creator: Roche Diagnostics Corp.
Published: 2007-05-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-05-15 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no... on 2007-05-15. The reason FDA records is "The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples". 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-0977-2007
Status: Terminated
Initiated: 2007-05-15
Posted: 2007-06-28
Terminated: 2008-06-11
Recalling firm: Roche Diagnostics GmbH
Product: Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic.
Product code: NHG Enzyme Immunoassay, Cortisol, Salivary
Reason for recall: The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm notified consignees via letter dated 5/15/07 and notifed them of the changes to functional sensitivity and between-run precision claims.
Quantity in commerce: 6051
Distribution: Nationwide.
Product codes and lots: Lots 17592001, exp. 10/31/07; 17502002, exp. 10/31/07; 17733201, exp. 2/29/08; and 17733202, exp. 2/29/08.

Product code NHG

K043175Class IIElecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. / cleared 2004-11-24

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)