Recall Z-1306-2014 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
| Date | Mar 27, 2014 (initiated Jan 1, 2014) |
| Status | Terminated |
| Reason | Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. |
| Root cause | Process control |
| Action | APOC sent an Urgent Recall Notice dated January 2014 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and provide a copy of this letter to any institution that was forwarded the affected product. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. To ensure continuity of supply at their facility, customers were instructed to follow their standard process to place an order or call Cu |
| Quantity | 48, 450 US, 1400 OUS (49,850 catridges) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to 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 |