Z-0104-2023Class II

Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay

Name: Z-0104-2023 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-09-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-09-19 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay on 2022-09-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0104-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-19
Posted: 2022-10-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Product code: NDW Assay, Porphyrin, Spectrophotometry, Lithium
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1342 US; 2266 OUS
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0104-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0104-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0105-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20

Product code NDW

K050374Class IIAdvia Ims Lithium AssayBayer Healthcare, LLC / cleared 2005-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)