Atellica CH UCFP (Siemens) – Quality Control Bias (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Siemens Material Number: 11097543, UDI-DI: 00630414279206, Lot number: 130414
Products Sold
Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 due to The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Recommended Action
Per FDA guidance
On July 29, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Impact to Results Erroneously depressed or elevated urine protein or cerebrospinal fluid patient results may occur. Siemens investigation revealed a positive bias of up to 52% (at 27.3 mg/dL (273 mg/L); up to 19% at 68.7 mg/dL (687 mg/L)). However, analyte recovery decreases rapidly after opening a reagent pack and a negative bias of up to -35% was observed at 24 hours (at 27 mg/dL (270 mg/L); up to -9% at 67 mg/dL (670 mg/L)). Results of this assay would be interpreted in conjunction with the patient s medical history, clinical presentation, and other findings. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lot listed in the table above (Products Section). 3. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. 4. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026