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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)

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 Class 2 Device Recall Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)see related information
Date Initiated by FirmAugust 11, 2025
Date PostedSeptember 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2542-2025
Recall Event ID 97398
Product Classification Biuret (colorimetric), total protein - Product Code CEK
ProductAtellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Code Information Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactJennifer Sacks
443-793-7288
Manufacturer Reason
for Recall		Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens Healthcare Diagnostics notified consignees on about 08/11/2025 via letter. Customers were instructed to perform QC on each well, track additional reagent consumption (number of tests) to report to Siemens Healthineers for future reimbursement/credit, review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and retain this letter with your laboratory records and forward this letter to those who may have received this product. Additionally, consignees were instructed to complete and return the Field Correction Effectiveness Check Form.
Quantity in Commerce11,811 units
DistributionWorldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, 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.
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