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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Revised CReactive Protein (RCRP)

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 Class 2 Device Recall Atellica CH Revised CReactive Protein (RCRP)see related information
Date Initiated by FirmAugust 17, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3335-2026
Recall Event ID 99726
510(K)NumberK221119 
Product Classification System, test, c-reactive protein - Product Code DCN
ProductAtellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Code Information Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSyreeta Wynn
914-413-5428
Manufacturer Reason
for Recall		The potential for falsely elevated results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 17, 2026 Urgent Medical Device Correction letters were sent to customers. Customer actions: 1. Follow the instructions provided to set-up and calibrate the device. 2. Record the number of unused tests discarded in Step 3 on the Field Correction Effectiveness Check form for reimbursement or credit. 3. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 4. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 5. Retain this letter with your laboratory records and forward this letter to those who may have received the affected product.
Quantity in Commerce42940 units (3938 US, 39002 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DCN
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