Recall Z-1684-2025 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; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
| Date | Apr 29, 2025 (initiated Mar 19, 2025) |
| Status | Open, Classified |
| Reason | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. |
| Root cause | Process control |
| Action | Consignees were sent an Urgent Medical Device Correction notice dated March 2025. The notification instructs consignees to review the provided notice with their medical director to determine the appropriate course of action. If affected devices were further distributed consignees are asked to forward the recall notification. Consignees are to return the provided Field Correction Effectiveness Check form within 7 days of receipt. The firm recommends that consignees stop injecting the sample as soon as the audio/visual cues are presented to minimize the potential for erroneous pH results. The c |
| Quantity | 264,252 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200107 | epoc Blood Analysis System Epocal, Inc., Jun 5, 2020 |