Siemens Atellica CH Lithium reagent recalled for potential reagent carryover
Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.
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 Class II medical device recall addresses a potential hazard (reagent carryover causing contamination) that could affect test accuracy, with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury in theoretical hazard scenarios score 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. issued a Class II recall of the Atellica CH Lithium_2 (LITH_2) laboratory reagent (Siemens Material Number 11097637). Approximately 2,158 units were distributed globally and throughout the United States. The affected lot numbers are: 110108, 110185, 110238, and 110302.
The company confirmed a potential for reagent carryover that could impact quality control (QC) results, patient samples, and calibrator results. Reagent carryover is a form of contamination that could affect the accuracy and reliability of laboratory test outcomes.
Healthcare facilities and laboratories using the affected lots should cease use of these reagents. Users should contact Siemens Healthcare Diagnostics, Inc. for guidance on replacement or return of affected units. Results generated with these reagents may require review to determine if retesting is necessary.
The recalled product
- Product
- Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- reagent-carryover
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00630414287935
- Lot Numbers: 110108 110185 110238 110302
Distribution
Distributed nationwide across the United States.
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