—#49521

Product

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

FDA product code: CFN — Method, Nephelometric, Immunoglobulins (G, A, M)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K982382
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-12-15
Posted by FDA: 2007-01-17
Terminated: 2008-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.