Atellica CH Lithium_2 (LITH_2), Siemens Material Number… recallZ-0104-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On September 19, 2022, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers should take the following actions: -Please review this letter with your Medical Director. -Discontinue use of and discard the affected product. Siemens is temporarily discontinuing production and distribution of the Atellica CH lithium reagents until the issue is resolved. In the interim, Siemens is recommending that customers transition to an alternate lithium assay.
Recall details
- Recall number
- Z-0104-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 19, 2022
- Posted by the FDA
- Oct 20, 2022
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1342 US; 2266 OUS
- Product code
- NDW
- FDA submissions
- K050374
- Distribution
- Worldwide distribution - US Nationwide.
Product description
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Code information (models, lots, serial numbers)
UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica CH Lithium_2 (LITH_2) 11532401Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium2 recalls0 reports
Other devices under the same FDA submission
2 devices cleared under K050374 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ADVIA® Chemistry Calibrator 10312279Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
- Atellica CH Li 11097535Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90900).
- Z-0105-2023 · Open, ClassifiedAtellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page