Recall Z-0104-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0104-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-19

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-09-19. It names one FDA 510(k) clearance: K050374. Product: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-19
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K050374 — ADVIA IMS LITHIUM ASSAYBayer Healthcare, LLC·cleared 2005-06-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.