Instrumentation Laboratory Co. GEM PREMIER 3000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GEM PREMIER 3000
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Serial numbers starting with 18412
Products Sold
Serial numbers starting with 18412
Instrumentation Laboratory Co. is recalling GEM PREMIER 3000 due to Software error may report higher results for glucose and lactate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software error may report higher results for glucose and lactate
Recommended Action
Per FDA guidance
Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006.
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