10

Apr

2025

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

0

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 4/10/2025
Class II

PRODUCT

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

Recall Number:

Z-1551-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

Siemens Healthcare Diagnostics, Inc.

VOLUME:

N/A

DISTRIBUTION:

Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Curacao, Seus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Saudi, Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United Kingdom, Uzbekistan, Vatican City.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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