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.
“Siemens Atellica CH Lithium Analyzer: False High Lithium Results Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60048-siemens-atellica-ch-lithium-analyzer-false-high-lithium-results-risk. Based on FDA recall #Z-0105-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0105-2023%22&limit=1).
The FDA announced on Sept. 19, 2022, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Lithium (Li) in vitro diagnostic assays due to the potential for falsely elevated lithium results. These errors may lead to inappropriate dosage adjustments affecting treatment efficacy.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Lithium (Li), Siemens Material Number 11097535.
Lots: 110354 exp 11/15/22; 120038 exp 2/7/23
Distribution: US Nationwide
The hazard
The recall addresses the potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. According to the FDA, erroneously elevated lithium patient results may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Magellan LeadCare II Blood Lead Test Kits (March 13, 2026), Magellan LeadCare Plus Blood Lead Test Kit (March 13, 2026), and Magellan LeadCare Ultra Blood Lead Test Kit (March 13, 2026).
How to tell if you have this one
Check for the Siemens Material Number 11097535 on the device. Affected lots are 110354 (expired 11/15/22) and 110038 (expired 2/7/23).
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-0104-2023
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay; UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23
1342 US; 2266 OUS
Z-0105-2023
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay; UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
586 US; 694 OUS
Based on the official FDA remedy
What to do — step by step
Check Device Lot Number
Look for the lot number on the device label to see if it's affected (110354 or 110038).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0105-2023 (September 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0105-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.