Home / Recalls / Siemens Healthcare Diagnostics Inc / Z-1684-2025

Z-1684-2025 Class II Ongoing

Recalled by Siemens Healthcare Diagnostics Inc — Norwood, MA

Recall Details

Product Type
Devices
Report Date
May 7, 2025
Initiation Date
March 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
264,252 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

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.

Other recalls by Siemens Healthcare Diagnostics Inc

  • Z-1484-2026 Class II — Atellica CH Urine Albumin (UAlb). Material Number: 11537225 (January 20, 2026)
  • Z-0491-2026 Class II — IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038610 (October 6, 2025)
  • Z-0493-2026 Class II — Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catal (October 6, 2025)
  • Z-0492-2026 Class II — 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj (October 6, 2025)
  • Z-0366-2026 Class II — Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN) (September 22, 2025)
  • Z-2542-2025 Class II — Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109754 (August 11, 2025)
  • Z-2272-2025 Class II — epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. (July 7, 2025)
  • Z-2230-2025 Class II — RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. (June 26, 2025)
  • Z-2088-2025 Class II — ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) (June 4, 2025)
  • Z-2086-2025 Class II — ADVIA¿ 120/2120/2120i SETpoint Calibrator (June 4, 2025)