FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
- Recall number
- Z-0846-03
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use
- Status
- Terminated
- Initiated
- 2003-03-07
- Posted
- 2003-05-20
- Terminated
- 2012-05-23
- Reason
- Incorrect bar code applied to cartridges could result in inaccurate pO2 value
- Root cause
- Other
- Action
- IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
- Quantity
- 2
- Distribution
- CA, FL, NY, PA, TN,
- Lot, serial or model codes
- Lot Number: 306360 Expires: 8/31/2003
- 510(k) numbers
- ["K992834"]
- 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