Recall Z-1372-2022 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
| Date | Jun 1, 2022 |
| Status | Open, Classified |
| Reason | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. |
| Root cause | Under Investigation by firm |
| Action | Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: Please dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or di |
| Quantity | 263 Boxes |
| Distribution | AL CA CO FL IA ID KS NM OK TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192240 | RAPIDPoint 500e Blood Gas System Siemens Healthcare Diagnostics, Inc., Mar 27, 2020 |