Reported Apr 16, 2025 · Ongoing

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005

Is this the product you have?

  • Atellica CH Revised C Reactive Protein (RCRP)
  • Siemens Material Number (SMN)11537223
Lot codes and dates
  • Siemens Material Number (SMN)11537223
  • UDI-DI00630414610887
  • Lot numbersAll lots
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.