Recall Z-2005-2026 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
| Date | Apr 29, 2026 (initiated Apr 2, 2026) |
| Status | Open, Classified |
| Reason | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter. |
| Root cause | Under Investigation by firm |
| Action | On April 2, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: Perform the instructions provided below: " Discontinue use of and discard the kit lots listed in the table above (Products Section). " Please review this letter with your Medical Director/POC Coordinator to determine the appropriate course of action, including for any previously generated results, if applicable. " Complete and return the Field Correction Effectiveness Check Form and Product Replacement Form attached to this letter within 30 days. " Adverse reactions or quality problems experienc |
| Quantity | 71725 (38025 US, 33700 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200107 | epoc Blood Analysis System Epocal, Inc., Jun 5, 2020 |