Recall Z-1621-2011 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
| Date | Mar 10, 2011 (initiated Sep 25, 2006) |
| Status | Terminated |
| Reason | Certain lots of G3+ cartridges may be difficult to fill. |
| Root cause | Other |
| Action | The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers. If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1. |
| Quantity | 12,675 in US, 125 ROW |
| Distribution | Worldwide distribution: USA and country of : Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER I-Stat Corp., May 10, 1994 |