Instrumentation Laboratory Co. GEM Premier 4000 Laboratory Analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GEM Premier 4000 Laboratory Analyzer
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Serial numbers prior to 07020343 with Software versions prior to V1.1.3
Products Sold
Serial numbers prior to 07020343 with Software versions prior to V1.1.3
Instrumentation Laboratory Co. is recalling GEM Premier 4000 Laboratory Analyzer due to Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026