Recall Z-2022-2011 ยท JGS Electrode, Ion Specific, Sodium
Abbott Point Of Care Inc.
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
| Date | Apr 18, 2011 (initiated Feb 15, 2011) |
| Status | Terminated |
| Reason | i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. |
| Root cause | Other |
| Action | The firm, Abbott Point of Care (APOC), sent an "Urgent Recall Notice" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the inst |
| Quantity | 6575 cartirdges |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbot I-Stat Corporation, Jan 13, 2006 |