Recall Z-0374-2008 ยท JGS Electrode, Ion Specific, Sodium
Abbott Point of Care Inc.
Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
| Date | Dec 11, 2007 (initiated Oct 18, 2007) |
| Status | Terminated |
| Reason | Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. |
| Root cause | Packaging change control |
| Action | 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. |
| Distribution | Worldwide Distribution- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-Stat Corp., Apr 18, 2000 |
| K894914 | MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK I-Stat Corp., Oct 16, 1989 |
| K912387 | I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK I-Stat Corp., Jul 1, 1991 |
| K936081 | I-STAT TESTS FOR ACID-BASE PARAMETERS I-Stat Corp., Feb 24, 1994 |