Siemens Healthcare Diagnostics Inc: Device Recall

Recall Details

Recall Number

Z-1685-2025

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Healthcare Diagnostics Inc

Status

Ongoing

Date Initiated

03/19/2025

Location

Norwood, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

5,207 units

Reason for Recall

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

Product Description

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.

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.

Other Recalls by Siemens Healthcare Diagnostics Inc

• Class II: Risk 10/06/2025
  The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
• Class II: Risk 10/06/2025
  The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
• Class II: Risk 10/06/2025
  The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
• Class II: Risk 09/22/2025
  The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
• Class II: Risk 08/11/2025
  Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

View all recalls by Siemens Healthcare Diagnostics Inc →