Roche/Hitachi Modular E Module immunoassay analyzer, Roche… recallZ-0165-2009 · Roche Diagnostics Corp. · initiated Jun 24, 2008
Terminated All recalls posted in October 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
A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
FDA root cause category: Other
What the company is doing
The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
Recall details
- Recall number
- Z-0165-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 24, 2008
- Posted by the FDA
- Oct 22, 2008
- Recalling firm
- Roche Diagnostics Corp.
- Product code
- JJE
- FDA submissions
- K961481
- Distribution
- Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
Product description
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
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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