Class 2 Device Recall epoc BGEM Crea Test Card

• Date Initiated by Firm: March 19, 2025
• Date Posted: April 29, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1685-2025
• Recall Event ID: 96539
• 510(K)Number: K200107
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: 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.
• Code Information: Siemens Material Number (SMN): 10736382; Udi-DI: 00809708072254; Lot Numbers: All lot numbers with prefix (xx) 00 or 06; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics Inc; 2 Edgewater Dr; Norwood MA 02062-4637
• For Additional Information Contact: Customer Service; 877-229-3711
• Manufacturer Reason for Recall: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
• FDA Determined 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 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.
• Quantity in Commerce: 5,207 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, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CHL