Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2471-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531

Product Classification:

Class II

Date Initiated: July 10, 2023

Date Posted: September 6, 2023

Recall Number: Z-2471-2023

Event ID: 92800

Reason for Recall:

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿CH HDL Cholesterol (HDLC)

Status: Ongoing

Product Quantity: 50148 units

Code Information:

Unique Device Identification (UDI): 00630414595818 All Lot Numbers

Distribution Pattern:

US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated