Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.

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 current affected software expires on 06/10/25 and the upgrade will include a correction for this issue. Consignees are to retain the recall notification with their manual or near the system for reference. Consignees with questions can call the Siemens Healthineers Technical Solutions Center at 877-229-3711.

• FDA enforcement recordOfficial FDA database entry for Z-1685-2025
• FDA 510(k) clearance · K200107The device's official FDA premarket clearance record
• FDA device classification · CHLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1120The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.