i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 10
FDA device recall Z-1171-06 · posted 2006-06-22 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained
- Action taken
- Recall letters were sent out via federal express and email notification was sent electronically with instructions as attachments during the period of 5/8/2006 through 6/7/2006 to include stop useage, and hold for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- JGS
- Quantity affected
- 59775 cartridges
- Distribution
- World wide ---There is only one US customer for these lots. The rest are international customers (Germany, Turkey, Hong Kong, Japan, Canada). There are no government accounts.
- Date initiated
- 2006-05-24
- Date posted
- 2006-06-22
- Date terminated
- 2007-08-15
- 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 |
|---|---|---|
| MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914) | I-Stat Corp. | 1989-10-16 |