GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (300 Sample Size) For In-Vitro D
FDA device recall Z-0845-03 · posted 2003-05-20 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- Reason for recall
- Incorrect bar code applied to cartridges could result in inaccurate pO2 value
- Action taken
- IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 16
- Distribution
- CA, FL, NY, PA, TN,
- Date initiated
- 2003-03-07
- Date posted
- 2003-05-20
- Date terminated
- 2012-05-23
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM PREMIER 3000 (K992834) | Instrumentation Laboratory CO | 1999-11-24 |