Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
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: This is an FDA Class II recall involving risk-of-harm products where inaccurate diagnostic test results could affect patient care, but no illness or injury has been reported according to the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Urine Albumin REF: 11537225, an in vitro diagnostic test, due to potential issues during processing on CI analyzers. The recall affects 7018 units distributed worldwide, including US nationwide distribution and numerous countries across multiple continents.
The recall is being issued because processing of the urine albumin assay on CI analyzers may lead to falsely depressed Atellica CH Urea Nitrogen (UN_c) results, falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results, an increased rate of reaction cuvette QC failures, and delayed results due to QC failures.
The affected products include all lots within expiry, identified by the UDI 00630414611099. The distribution covers worldwide markets including the US (including Puerto Rico), Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare facilities and laboratories using the Atellica CH Urine Albumin assay on CI analyzers should contact Siemens Healthcare Diagnostics for further instructions regarding the recall. No specific consumer action is required at this time, but medical professionals should be aware of the potential for inaccurate test results.
The recalled product
- Product
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,018
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 (1)
- All Lots within expiry/UDI: 00630414611099
Distribution
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