Siemens Healthcare Diagnostics Inc: Device Recall

Recall Details

Recall Number

Z-1673-2025

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Healthcare Diagnostics Inc

Status

Ongoing

Date Initiated

03/31/2025

Location

Norwood, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

367 units

Reason for Recall

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

Product Description

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & 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 →