Recall Z-0846-03 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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
| Date | May 20, 2003 (initiated Mar 7, 2003) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992834 | GEM PREMIER 3000 Instrumentation Laboratory CO, Nov 24, 1999 |