Recall Z-2542-2025— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2025-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.. Reason: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-11
- Firm location
- Tarrytown, NY, United States
Product description
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Reason for recall
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.