FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1684-2025
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2025-03-19
- Posted
- 2025-04-29
- Terminated
- not on file
- 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 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
- 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, 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.
- Lot, serial or model codes
- Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; 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.
- 510(k) numbers
- ["K200107"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28