Medical device assay may report falsely elevated lithium levels
Siemens' Atellica CH Lithium diagnostic assay may falsely report elevated lithium levels, potentially leading to incorrect dose adjustments in patients on lithium therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a diagnostic assay with potential to produce falsely elevated patient test results that could lead to incorrect medication dosing. While no illnesses or injuries are reported in the source, the risk to patient treatment efficacy meets the criteria for High severity.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica CH Lithium (Li) in vitro diagnostic assay (Siemens Material Number 11097535). The recall affects approximately 586 units in the United States and 694 units internationally. The affected lots are 110354 (expiring 11/15/22) and 120038 (expiring 2/7/23).
The assay may produce falsely elevated LITH_2 and lithium results when used on the Atellica CH 930 Analyzer. These false elevations could prompt clinicians to reduce patient lithium doses unnecessarily, potentially compromising the effectiveness of lithium therapy.
Laboratories and healthcare facilities using this assay are affected by this recall. Healthcare providers should review recent lithium test results for patients tested with affected inventory and consider whether dose adjustments were made based on these results. Providers should consult with Siemens Healthcare Diagnostics regarding replacement assay inventory or additional verification testing for affected patients.
The recalled product
- Product
- Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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