Recall Z-0778-2007
Instrumentation Laboratory Co. · initiated March 27, 2007
Product
GEM Premier 4000 Laboratory Analyzer
Codes / lots: Serial numbers prior to 07020343 with Software versions prior to V1.1.3
Reason for recall
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
FDA-determined 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
Details
- Recall number
- Z-0778-2007
- Initiated
- March 27, 2007
- Posted by FDA
- May 3, 2007
- Terminated
- May 23, 2012
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Quantity
- 210
- Distribution
- Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
- Recalling firm
- Instrumentation Laboratory Co., Lexington, MA