Recall Z-1171-06 ยท JGS Electrode, Ion Specific, Sodium
Abbott Laboratories
i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02.
| Date | Jun 22, 2006 (initiated May 24, 2006) |
| Status | Terminated |
| Reason | Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894914 | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK I-Stat Corp., Oct 16, 1989 |