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Terminated

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

FDA Recall Z-0356-2007 · Posted 2007-01-17

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCFN
Date Initiated2006-12-15
Date Terminated2008-04-23
Product Quantity18,905

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982382COBAS INTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc. · 1998-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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