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Recall Observatory FDA recall evidence

Device product

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

Z-0104-2023

September 19, 2022

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 90900
Status
Ongoing
Classification
Class II
Quantity
1342 US; 2266 OUS
Official record key
device-enforcement:Z-0104-2023

Official wording

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.

Code information: UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23

Distribution pattern: Worldwide distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.