Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Summary
The FDA issued a Class II for Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic by Siemens Healthcare Diagnostics, Inc.. Reason: Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Fa.
Details
Source
Device Recall
External ID
Z-2890-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Lot/Code Info: All Lots within expiry/UDI: 00630414611099
Quantity Affected: 7018 units
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.
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.¿
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-06
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 165 FDA actions in our database, including 142 recalls and 23 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 165 FDA actions in our database, including 142 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2890-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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