Urinary protein assay recalled over falsely depressed patient and calibration results
Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the assay can produce falsely depressed patient results and no injuries are reported.
Plain-English summary
The Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) assay, material number 11097543, test code UCFP, UDI-DI 00630414279206, is being recalled across all lot numbers. The recall covers 11,811 units distributed in the United States and in many other countries.
The recall was issued because of the potential for falsely depressed patient, quality control and/or calibration results, or delayed results. The FDA classified the action as Class II.
Laboratories using this assay should follow the manufacturer's instructions, including any guidance on reviewing results already reported.
The recalled product
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 11,811
Distribution
Distributed nationwide across the United States.
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