The Recall Desk
HighFDA (Devices)·Z-0180-2022·Announced 2021-11-03

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.

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 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.
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
  • reagent-carryover
  • test-result-inaccuracy

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.

Related recalls

Same category