Z-0356-2007

Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic

Name: Z-0356-2007 Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic
Creator: Roche Diagnostics Corp.
Published: 2006-12-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-12-15 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic on 2006-12-15. The reason FDA records is "Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0356-2007
Status: Terminated
Initiated: 2006-12-15
Posted: 2007-01-17
Terminated: 2008-04-23
Recalling firm: Roche Diagnostics GmbH
Product: Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant Hemoglobin A1c assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 800 analyzer.
FDA root cause: Other
Action: Device correction letters dated 12/15/06 instructing users to perform an extra wash cycle between applications when using both the ALBT2 and IGGT cassettes on the COBAS INTEGRA 700 and 800 analyzers. The recall was extended to via device correction letters dated 2/28/07 instructing users to perform an extra wash cycle between applications when using both the A1C2 and IGGT cassettes on the COBAS INTEGRA 800 analyzer.
Quantity in commerce: 18,905
Distribution: Nationwide.
Product codes and lots: Lots: 66160001; exp. 12/31/06; 66395101, exp. 2/28/07; 67306401, exp. 1/31/08; 66954901, exp. 5/31/07; 67589901, exp. 4/30/08 and 68049501, exp. 10/31/08.

Product code CFN

K982382Class IICobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. / cleared 1998-09-28

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)