i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540
FDA device recall Z-0317-2011 · posted 2010-11-03 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
- Action taken
- Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 482,500 (total number)
- Distribution
- Worldwide Distribution: USA and Canada.
- Date initiated
- 2008-01-01
- Date posted
- 2010-11-03
- Date terminated
- 2011-09-14
- 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 CREATINE KINASE MB (CK-MB) (K051433) | I-Stat Corporation | 2005-12-15 |