The Recall Desk
HighFDA (Devices)·Z-0181-2022·Announced 2021-11-03

Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results

Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.

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 is a risk-of-harm medical device where injury has not yet been reported. While classified as FDA Class II, the recall involves potential for inaccurate diagnostic test results that could affect treatment decisions, but no actual patient harm or hospitalizations are documented.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagent. The recall affects all lots of this diagnostic reagent.

The firm has confirmed a potential for reagent carryover that can impact Enzymatic Hemoglobin A1c test results. Specifically, the carryover can cause Hemoglobin A1c results to be falsely depressed (lower than they should be). Falsely low A1c results may affect the consideration of appropriate patient intervention or treatment decisions.

This reagent is used in clinical laboratories that operate Advia Chemistry analyzers. Affected units are distributed worldwide, including 246 units in the United States and 689 units outside the United States.

Healthcare facilities using this reagent should contact Siemens Healthcare Diagnostics for guidance on this recall. Laboratories should review any A1c results obtained with affected reagent lots and consider whether repeat testing may be warranted for patient management decisions.

The recalled product

Product
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic Reagent / Laboratory Test
Hazard
  • reagent-carryover
  • inaccurate-test-results

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