Recall MonitorHealth Products
Atellica® CH Urine Albumin (UAlb)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Atellica® CH Urine Albumin (UAlb)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Atellica® CH Urine Albumin (UAlb) | More than 10 numbers, contact manufacturer. | 11537225 |
Issue
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 failuresThese issues may impact quality control (QC), calibrators, and patient results for the UN_c and A1c_E assays across all sample types.