Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
This recall has been terminated (originally issued January 17, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- December 15, 2006
- Posted
- January 17, 2007
- Terminated
- April 23, 2008
- Recall Number
- Z-0356-2007
- Quantity
- 18,905
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
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.
Root Cause
Other
Action Taken
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.