Siemens Atellica CH diagnostic reagent batch may produce biased results
A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.
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 a Class II medical device recall involving a diagnostic reagent with potential for biased quality control and inaccurate patient test results. No illnesses or injuries have been reported, making this a risk-of-harm product without reported actual harm, per the rubric.
Plain-English summary
This recall affects lot 130414 of the Siemens Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) reagent. This product is used as a control or calibration reagent in clinical laboratory testing with the Atellica CH analyzer.
The manufacturer identified a potential for biased quality control results and inaccurate patient test outcomes when using this specific lot. The reagent may not perform as intended, which could affect the accuracy of diagnostic test results.
Approximately 229 units were distributed in the United States (in California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Mississippi, New Jersey, New York, Nevada, Pennsylvania, Texas, Virginia, and Puerto Rico), with an additional 935 units distributed internationally to numerous countries. Clinical laboratories, hospitals, and other healthcare facilities using this reagent are affected.
Healthcare facilities with lot 130414 should contact Siemens Healthcare Diagnostics for further information and guidance regarding this quality control issue.
The recalled product
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (3)
- Siemens Material Number: 11097543
- UDI-DI: 00630414279206
- Lot number: 130414
Distribution
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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