Recall Z-0286-2025 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, SMN 10736515
| Date | Nov 1, 2024 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| Reason | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction letter dated September 2024 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " If you are a distributor, please ensure your customers receive this UMDC letter. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the |
| Quantity | 1292 units |
| Distribution | US Nationwide. Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200107 | epoc Blood Analysis System Epocal, Inc., Jun 5, 2020 |