United StatesAtellica CH Urine Albumin (UAlb) test reagents, Material Number 11537225 (UDI‑DI 00630414611099), all lot numbers, distributed worldwide including the United States, are affected. They were recalled because samples with urine albumin concentrations above the UAlb measuring interval (>40.0 mg/dL) may report falsely depressed results between 6.2 mg/dL and 40.0 mg/dL.
What's being recalled
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Recalling firm: Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States.
How to identify it
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
The hazard
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
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 and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, 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)