Siemens Healthcare Diagnostics, Inc. Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
Products Sold
UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026