Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct); List No: 06F07-01; Part No: 121500; Abbott Point of Care In
FDA device recall Z-0372-2008 · posted 2007-12-11 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
- Action taken
- Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- JGS
- Distribution
- Worldwide Distribution- including USA and country of Canada.
- Date initiated
- 2007-10-18
- Date posted
- 2007-12-11
- Date terminated
- 2008-07-18
- Location
- East Windsor, 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 MODEL 200 PORTABLE CLINICAL ANALYZER (K001154) | I-Stat Corp. | 2000-04-18 |
| I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK (K912387) | I-Stat Corp. | 1991-07-01 |
| MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914) | I-Stat Corp. | 1989-10-16 |