Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0928-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

Product Classification:

Class II

Date Initiated: February 9, 2022

Date Posted: April 20, 2022

Recall Number: Z-0928-2022

Event ID: 89740

Reason for Recall:

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

Status: Ongoing

Product Quantity: 2,395

Code Information:

UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526

Distribution Pattern:

Global Distribution. US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated