GEM PREMIER 3000
This recall has been terminated (originally issued January 11, 2006).
- Company
- Instrumentation Laboratory Co.
- Recall Initiated
- December 16, 2005
- Posted
- January 11, 2006
- Terminated
- May 21, 2007
- Recall Number
- Z-0378-06
- Quantity
- 2021 units
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Software error may report higher results for glucose and lactate
Distribution
Nationwide Foreign: Canada
Lot / Code Info
Serial numbers starting with 18412
Root Cause
Other
Action Taken
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.
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