GEM Premier 4000 Laboratory Analyzer
This recall has been terminated (originally issued May 3, 2007).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- March 27, 2007
- Posted
- May 3, 2007
- Terminated
- May 23, 2012
- Recall Number
- Z-0778-2007
- Quantity
- 210
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
Distribution
Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
Lot / Code Info
Serial numbers prior to 07020343 with Software versions prior to V1.1.3
Root Cause
Other
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
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