Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0180-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Product Classification:

Class II

Date Initiated: September 20, 2021

Date Posted: November 3, 2021

Recall Number: Z-0180-2022

Event ID: 88784

Reason for Recall:

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

Status: Ongoing

Product Quantity: 1402 (US); 2941 (OUS)

Code Information:

All lots impacted

Distribution Pattern:

Worldwide distribution - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated