Recall Z-0378-06 ยท CGA Glucose Oxidase, Glucose
Instrumentation Laboratory Co.
GEM PREMIER 3000
| Date | Jan 11, 2006 (initiated Dec 16, 2005) |
| Status | Terminated |
| Reason | Software error may report higher results for glucose and lactate |
| Root cause | Other |
| Action | 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. |
| Quantity | 2021 units |
| Distribution | Nationwide Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052121 | GEM PREMIER 3000 Instrumentation Laboratory CO, Oct 21, 2005 |