United StatesAtellica CH Urine Albumin REF 11537225 (in vitro diagnostic), all lots within expiry/UDI 00630414611099, is being recalled; 7,018 units were distributed worldwide. The recall was issued because processing the urine albumin assay on CI analyzers may produce falsely depressed Atellica CH Urea Nitrogen (UN_c) and Enzymatic Hemoglobin A1c (A1c_E) results, increase reaction cuvette QC failures, and delay results due to QC failures.
What's being recalled
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Recalling firm: Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States.
How to identify it
All Lots within expiry/UDI: 00630414611099
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.¿
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)