Siemens Atellica CH Urine Albumin test recalled for false results
Siemens Healthcare Diagnostics is recalling the Atellica CH Urine Albumin test (REF 11537225) used on CI analyzers. The test may produce falsely low urea nitrogen and hemoglobin A1c results, and may cause more quality control failures that delay results.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- Check whether your lab uses Atellica CH Urine Albumin REF 11537225 on CI analyzers.
- Contact Siemens Healthcare Diagnostics for guidance on affected lots and any corrective steps.
- Review recent urea nitrogen and A1c results from affected runs with your clinical team.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 7018 units
- Illnesses reported
- None reported
- Manufactured in
- 511 Benedict Ave, Tarrytown, NY, United States
- Classification
- Class II
- Recall number
- Z-2890-2026
In the FDA's words
- Description
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. All Lots within expiry/UDI: 00630414611099 Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, 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, United¿Kingdom.¿ Affected quantity: 7018 units
- Hazard
- Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
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