Siemens urine albumin assay may report falsely depressed patient results
Siemens Healthcare Diagnostics is recalling all lots of the Atellica CH Urine Albumin assay because falsely depressed patient results may occur above the measuring interval.
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 assay can under-report patient results across the whole range above its measuring interval, and no injuries are stated in the source.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Urine Albumin (UAlb) assay, material number 11537225. About 4,885 units were distributed worldwide, covering the United States nationwide and more than thirty other countries. The FDA has classified this recall as Class II.
Falsely depressed urine albumin patient results may occur. Affected samples with any urine albumin concentration above the measuring interval of 40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
All lot numbers are affected. The product carries UDI-DI 00630414611099.
Laboratories can identify affected product by the material number and UDI above, and may contact Siemens Healthcare Diagnostics, Inc. for further information.
The recalled product
- Product
- Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 4,885
Distribution
Distributed nationwide across the United States.
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