Medical Device Recall: Z-0104-2023

FDA Recalls dataset · Firm: Siemens Healthcare Diagnostics, Inc. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2022-09-19 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0104-2023.

Recall Res Number
Z-0104-2023
Recalling Firm / Manufacturer
Siemens Healthcare Diagnostics, Inc.
FEI Number
2432235
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2022-09-19
Date Posted
2022-10-20
Date Terminated
N/A
Product Code
NDW
Event Number
90900
Product Quantity
1342 US; 2266 OUS
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.
Action Details 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.
Distribution Pattern Worldwide distribution - US Nationwide.
Code Information / Serial Numbers UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

Related Establishments / Registrations

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