CanadaThe Atellica CH Urine Albumin (UAlb) reagent used for processing UAlb tests on Atellica CH and Atellica CI analyzers is affected (model/catalogue number 11537225; multiple lot/serial numbers—contact the manufacturer). Siemens Healthineers confirmed potential for falsely depressed Atellica CH Urea Nitrogen (UN_c) and enzymatic Hemoglobin A1c (A1c_E) results and an increased rate of reaction cuvette QC failures that may impact QC, calibrators, and patient results for the UN_c and A1c_E assays across all sample types; contact the manufacturer for additional information.
What's being recalled
Companies: Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, New York, United States, 10591.
How to identify it
Affected products: Atellica® CH Urine Albumin (UAlb); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 11537225
The hazard
Siemens Healthineers has confirmed, through the investigation of customer complaints, the potential for the following issues associated with processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers.
• 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
These issues may impact quality control (QC), calibrators, and patient results for the UN_c and A1c_E assays across all sample types.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)