Roche COBAS c 111 Analyzer with ISE module option, GMMI No.… recallZ-1009-2009 · Roche Diagnostics Corp. · initiated Nov 17, 2008
Terminated All recalls posted in March 2009
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
Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, con
FDA root cause category: Nonconforming Material/Component
What the company is doing
Consignees were notified via an Urgent Medical Device Correction letter dated 11/17/08 and instructed Roche will contact them to make an appointment to inspect their analyzers. A work around was provided, for interim use, in the letter. Customers were instructed to complete and fax back the "ISE Controls Request - Purchased from a Distributor." A no charge replacement product will be shipped to customers.
Recall details
- Recall number
- Z-1009-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 17, 2008
- Posted by the FDA
- Mar 24, 2009
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 66
- Product code
- JJE
- FDA submissions
- K071211
- Distribution
- Nationwide Distribution
Product description
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
Code information (models, lots, serial numbers)
Serial numbers: 50654, 50694, 50541, 50634, 50251, 50506, 50453, 50688, 50244, 50475, 50597, 50656, 50598, 50635, 50632, 50586, 50320, 50246, 50693, 50692, 50562, 50547, 50624, 50690, 50687, 50680, 50560, 50247, 50538, 50633, 50201, 50612, 50576, 50689, 50681, 50424, 50651, 50661, 50452, 50450, 50290, 50630, 50319, 50250, 50549, 50682, 50683, 50685, 50660, 50545, 50463, 50655, 50539, 50653, 50249, 50563, 50561, 50686, 50649, 50470, 50657, 50448, 50644, 50595, 50575, and 50679.
Other devices under the same FDA submission
2 devices cleared under K071211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Glucose HK 4657527190Roche Diagnostics GmbH · HEXOKINASE, GLUCOSE7 reports
- ISE Sodium Electrode 4838084001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM3 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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