Z-0104-2023 Class II Ongoing
FDA device recall Z-0104-2023 was initiated by Siemens Healthcare Diagnostics, Inc. on Sep 19, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1342 US; 2266 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 26, 2022
- Initiation Date
- Sep 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1342 US; 2266 OUS
Product Description
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0104-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026