Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0105-2023)

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 Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

Product Classification:

Class II

Date Initiated: September 19, 2022

Date Posted: October 26, 2022

Recall Number: Z-0105-2023

Event ID: 90900

Reason for Recall:

Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.

Status: Ongoing

Product Quantity: 586 US; 694 OUS

Code Information:

UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated