Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1484-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Product Classification:

Class II

Date Initiated: January 20, 2026

Date Posted: March 11, 2026

Recall Number: Z-1484-2026

Event ID: 98370

Reason for Recall:

Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

Status: Ongoing

Product Quantity: 4,885 units

Code Information:

Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated