Recall Z-0881-2021 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
| Date | Dec 22, 2020 |
| Status | Terminated |
| Reason | Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y. |
| Root cause | Under Investigation by firm |
| Action | Abbott Point of Care notified Customers via email beginning on 22 December 2020. Customer letters will begin shipping via FedEx on 28-December-2020 for delivery on or around 29-December-2020. Letter states reason for recall, health risk and action to take: While Abbott Point of Care continues to investigate this issue, if reporting ionized calcium is required, it is recommended that the i-STAT CG8+ and EG7+ cartridges be used only: within 3 days of removal from refrigerated storage for lot numbers between *20100 and *20339 within 7 days of removal from refrigerated storage for lot numbers * |
| Quantity | 1,521,800 cartridges US and 2,641,053 cartridges OUS |
| Distribution | 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 |