ADVIA Chemistry urinary protein reagent quality control failure
Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.
What this means for you
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: FDA Class II medical device with quality control issues affecting diagnostic accuracy. No illnesses or injuries reported in the source text, making this a risk-of-harm product where potential injury has not yet been reported, which places it at score 3 per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) test reagents, specifically lot 140. The recall also affects Atellica CH UCFP lot 130414. These are laboratory test reagents used in clinical settings to measure protein levels in urine and cerebrospinal fluid samples.
The recall is due to potential quality control failures that could result in biased or inaccurate test results. If test results are inaccurate, patients could receive incorrect diagnoses or treatment decisions based on these flawed results.
A total of 143 units have been distributed worldwide, including 17 units in the United States distributed across 15 states and Puerto Rico. International distribution includes Australia, Austria, Canada, and many other countries.
Healthcare facilities and laboratories that have received these reagent lots should stop using them and contact Siemens Healthcare Diagnostics for instructions on replacement product and verification of affected test results.
The recalled product
- Product
- ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- quality-control-failure
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Siemens Material Number: 11319151
- UDI-DI: 00630414279176
- Lot number: 140
Distribution
Distributed nationwide across the United States.
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