Siemens Healthcare Diagnostics, Inc.: Device Recall

Recall Details

Recall Number

Z-3305-2024

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Healthcare Diagnostics, Inc.

Status

Ongoing

Date Initiated

08/21/2024

Location

Tarrytown, NY, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

9783 kits

Reason for Recall

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Product Description

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Distribution Pattern

Worldwide distribution - US Nationwide.

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. →