Recall Z-0778-2007 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Instrumentation Laboratory Co.
GEM Premier 4000 Laboratory Analyzer
| Date | May 3, 2007 (initiated Mar 27, 2007) |
| Status | Terminated |
| Reason | Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result |
| Root cause | Other |
| Action | Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07 |
| Quantity | 210 |
| Distribution | Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT Instrumentation Laboratory CO, Sep 15, 2006 |