CanadaThe Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay (model/catalogue number 11097536), all lots, used on Atellica CH and Atellica CI systems is affected. Siemens Healthcare Diagnostics has confirmed an intermittent well-to-well bias that can cause falsely depressed or falsely elevated patient results depending on whether an affected well is used for calibration or testing, and affected wells cannot be identified prospectively. 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 Enzymatic Hemoglobin A1c (A1c_E) assay; Lot or serial number: All lots.; Model or catalogue number: 11097536
The hazard
Siemens Healthineers has confirmed, through internal investigation of customer complaints, the potential for intermittent well-to-well bias affecting the A1c_E/A1c_H assay when used on the Atellica CH and Atellica CI systems. This observed bias does not affect every A1c_E reagent lot or reagent pack. However, affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted until further notice. Under certain circumstances, this issue may result in:
. Falsely depressed patient results when lot calibration is performed using an affected well and patient testing is subsequently performed using an unaffected well.
. Falsely elevated patient results when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well.
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)