Roche/Hitachi Modular Analytics System, Modular E Module… recallZ-0868-2008 · Roche Diagnostics Corp. · initiated Mar 21, 2008
Terminated All recalls posted in August 2008
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
Possible mismatch between patient and result.
FDA root cause category: Process change control
What the company is doing
Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.
Recall details
- Recall number
- Z-0868-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 21, 2008
- Posted by the FDA
- Aug 13, 2008
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 11 of all models.
- Product code
- JJE
- FDA submissions
- K961481
- Distribution
- Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
Product description
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
Code information (models, lots, serial numbers)
All units with software version 08-02.
Other devices under the same FDA submission
2 devices cleared under K961481 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- cobas e 411 Immunoassay Analyzer 04775201001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE685 reports
- cobas e 411 Immunoassay Analyzer 04775279001Roche Diagnostics GmbH · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE533 reports
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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