Atellica CH Li 11097535Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K050374); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 19, 2022Class IIOpen, Classified

   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.

   Z-0105-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050374. One submission often covers many models, so check the product and lot details in each record.

• Z-0104-2023 · Sep 19, 2022 · Open, Classified
  Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
• Z-0931-2022 · Feb 9, 2022 · Open, Classified
  Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
• Z-2430-2020 · Jun 5, 2020 · Terminated
  ADVIA Chemistry Calibrator
• Z-0589-2017 · Oct 7, 2016 · Terminated
  Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), To
• Z-0365-2014 · Sep 24, 2013 · Terminated
  Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Pr