Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
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- Company / brand
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.¿
- Recall initiated
- 2026-07-06
- Code info
- All Lots within expiry/UDI: 00630414611099
- Product quantity
- 7018 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tarrytown
- State
- NY
- Country
- United States
- Event id
- 99389
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