GEM PREMIER 3000
FDA device recall Z-0378-06 · posted 2006-01-11 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Software error may report higher results for glucose and lactate
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 2021 units
- Distribution
- Nationwide Foreign: Canada
- Date initiated
- 2005-12-16
- Date posted
- 2006-01-11
- Date terminated
- 2007-05-21
- Location
- Lexington, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM PREMIER 3000 (K052121) | Instrumentation Laboratory CO | 2005-10-21 |