Recall Z-1265-2020 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
| Date | Feb 18, 2020 (initiated Jan 14, 2020) |
| Status | Terminated |
| Reason | Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020. |
| Root cause | No Marketing Application |
| Action | On January 15, 2020, the recalling firm notified customers via letters, emails, follow-up phone calls/visits by sales representatives, and a website posting at www.pointofcare.abbott. Customers were instructed to take the following actions: " During the transition, clinicians and laboratory staff should be informed that the performance of the i-STAT G3+ (BLUE) cartridge has not been fully characterized by Abbott. " Clinicians should be advised to consider a patients signs, symptoms, history, and results of other diagnostic tests when interpreting results from these cartridges. If the result |
| Quantity | 4,448,525 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.