Z-1009-2009

Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN...

Name: Z-1009-2009 Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN...
Creator: Roche Diagnostics Corp.
Published: 2008-11-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2008-11-17 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of... on 2008-11-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1009-2009
Status: Terminated
Initiated: 2008-11-17
Posted: 2009-03-24
Terminated: 2009-12-08
Recalling firm: Roche Diagnostics GmbH
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 66
Distribution: Nationwide Distribution
Product codes and lots: 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.

Product code JJE

K071211Class IICobas C 111 AnalyzerRoche Diagnostics / cleared 2007-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)