Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-v
FDA device recall Z-1009-2009 · posted 2009-03-24 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 66
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-11-17
- Date posted
- 2009-03-24
- Date terminated
- 2009-12-08
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBAS C 111 ANALYZER (K071211) | Roche Diagnostics | 2007-07-30 |