FDAClass IIApril 16, 2025

Atellica CH Revised C Reactive Protein recall: Software Issue

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

Why was Atellica CH Revised C Reactive Protein recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.

Product
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
N/A
Distribution
Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, 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, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Recall date
April 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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