I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitat
FDA device recall Z-2133-2012 · posted 2012-08-02 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
- Action taken
- Abbott Point of Care, Inc sent a Urgent Recall Notice letter dated January 14, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of Cartridges from the identified lot. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. If you have any questions regarding this information please contact your Abbott Point of Care Technical Support at 800-366-8020 Option 1, or your Abbott Point of Care representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 52,750 cartridges
- Distribution
- USA ( nationwide )
- Date initiated
- 2011-01-01
- Date posted
- 2012-08-02
- Date terminated
- 2013-05-22
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT 200 PORTABLE CLINICAL ANALYZER (K940918) | I-Stat Corp. | 1994-05-10 |