Siemens Healthcare Diagnostics, Inc.: Device Recall

Recall Details

Recall Number

Z-0496-2025

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Healthcare Diagnostics, Inc.

Status

Ongoing

Date Initiated

10/21/2024

Location

Tarrytown, NY, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

9729 units

Reason for Recall

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

Product Description

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.

Distribution Pattern

US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Libya Malaysia Mexico Moldova, Rep. of Morocco Nepal Netherlands Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity 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. →