Recall Z-0356-2007 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Roche Diagnostics Corp.
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
| Date | Jan 17, 2007 (initiated Dec 15, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 18,905 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982382 | COBAS INTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc., Sep 28, 1998 |