Lithium diagnostic assay may display falsely elevated results on Atellica CH analyzer
The Atellica CH Lithium_2 diagnostic assay may produce falsely elevated lithium readings on the Atellica CH 930 analyzer, potentially leading to incorrect medication dosage adjustments. No illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall with potential to cause harm through inaccurate treatment decisions. No illnesses or injuries have been reported, and the hazard is described as potential rather than confirmed, which per the rubric qualifies this as High (3).
Plain-English summary
Siemens Healthcare Diagnostics has recalled the Atellica CH Lithium_2 (LITH_2) in vitro diagnostic assay (Material Number 11532401), which measures lithium levels in patient blood samples on the Atellica CH 930 analyzer.
The assay has a potential to produce falsely elevated lithium readings. In the worst case, this could result in erroneously elevated lithium patient results, which may lead healthcare providers to make inappropriate medication dosage adjustments. No illnesses or injuries have been reported in connection with this issue.
The recall affects 1,342 units distributed in the United States and 2,266 units distributed outside the United States. The affected lot numbers are: 110238 (expiring 10/18/22), 110302 (expiring 12/13/22), and 120017 (expiring 4/18/23). Healthcare facilities currently using this assay should verify their lot numbers against the recall information and contact Siemens directly for remediation guidance.
The recalled product
- Product
- Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. 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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