FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: GEM PREMIER 3000
- Recall number
- Z-0378-06
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- GEM PREMIER 3000
- Status
- Terminated
- Initiated
- 2005-12-16
- Posted
- 2006-01-11
- Terminated
- 2007-05-21
- 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
- Lot, serial or model codes
- Serial numbers starting with 18412
- 510(k) numbers
- ["K052121"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 1217183
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28