i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is
FDA device recall Z-1621-2011 · posted 2011-03-10 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- Certain lots of G3+ cartridges may be difficult to fill.
- Action taken
- The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers. If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 12,675 in US, 125 ROW
- Distribution
- Worldwide distribution: USA and country of : Canada.
- Date initiated
- 2006-09-25
- Date posted
- 2011-03-10
- Date terminated
- 2012-02-27
- 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 |