FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: GEM Premier 4000 Laboratory Analyzer
- Recall number
- Z-0778-2007
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- GEM Premier 4000 Laboratory Analyzer
- Status
- Terminated
- Initiated
- 2007-03-27
- Posted
- 2007-05-03
- Terminated
- 2012-05-23
- Reason
- Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
- Root cause
- Other
- Action
- Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07
- Quantity
- 210
- Distribution
- Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
- Lot, serial or model codes
- Serial numbers prior to 07020343 with Software versions prior to V1.1.3
- 510(k) numbers
- ["K061974"]
- PMA numbers
- not on file
- Product code
- CHL
- 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