- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- All Lots within expiry/UDI: 00630414611099
- Units affected
- 7018 units
- Distribution pattern
- 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.¿
- Firm location
- Tarrytown, NY, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2890-2026
- Recall initiated
- July 6, 2026
- FDA classification date
- August 5, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99389
- Last updated on HTM Vibe
- August 18, 2026