Siemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.
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 FDA Class II medical device recall involves a confirmed functional defect in a diagnostic reagent that can produce inaccurate results affecting clinical decision-making. No illnesses or injuries have been reported. Per the rubric, recalls involving risk-of-harm products without reported injury are scored as High severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) reagent. The recall affects all lots of this in vitro diagnostic reagent.
The firm has confirmed potential for reagent carryover that impacts results of the Enzymatic Hemoglobin A1c (A1c) test. This carryover causes the test results to be falsely depressed, which may affect consideration of medical intervention in patient care.
The affected reagent has been distributed worldwide, with approximately 1,402 units in the United States and approximately 2,941 units distributed outside the United States.
The recalled product
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), 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 (1)
- All lots impacted
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.
See all 2 products in this recall →Related recalls
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