Health product recall

Atellica® CH Urine Albumin (UAlb)

Last updated

Summary

Product
Atellica® CH Urine Albumin (UAlb)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected 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 failures
These issues may impact quality control (QC), calibrators, and patient results for the UN_c and A1c_E assays across all sample types.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave, Tarrytown, New York, United States, 10591

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82353

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