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Open, Classified

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

FDA Recall Z-0104-2023 · Posted 2022-10-20

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeNDW
Date Initiated2022-09-19
Product Quantity1342 US; 2266 OUS

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050374ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC · 2005-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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