Recall Z-2133-2012 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
| Date | Aug 2, 2012 (initiated Jan 1, 2011) |
| Status | Terminated |
| Reason | i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer. |
| Root cause | Nonconforming Material/Component |
| Action | Abbott Point of Care, Inc sent a Urgent Recall Notice letter dated January 14, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of Cartridges from the identified lot. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. If you have any questions regarding this information please contact your Abbott Point of Care Technical Support at 800-366-8020 Option 1, or your Abbott Point of Care representative. |
| Quantity | 52,750 cartridges |
| Distribution | USA ( nationwide ) |
| 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 |