—#196169

Product

Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

FDA product code: NDW — Assay, Porphyrin, Spectrophotometry, Lithium
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K050374
Affected lot / code info: UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide distribution - US Nationwide.

Timeline

Recall initiated: 2022-09-19
Posted by FDA: 2022-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.