Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric) recallZ-0356-2007 · Roche Diagnostics Corp. · initiated Dec 15, 2006
Terminated All recalls posted in January 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0356-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 15, 2006
- Posted by the FDA
- Jan 17, 2007
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 18,905
- Product code
- CFN
- FDA submissions
- K982382
- Distribution
- Nationwide.
Product description
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
1 device cleared under K982382 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Immunoglobulin M 20737771322Roche Diagnostics GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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