GEM Premier 4000 Laboratory Analyzer
FDA device recall Z-0778-2007 · posted 2007-05-03 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 210
- Distribution
- Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
- Date initiated
- 2007-03-27
- Date posted
- 2007-05-03
- Date terminated
- 2012-05-23
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT (K061974) | Instrumentation Laboratory CO | 2006-09-15 |