Atellica CH Ethyl Alcohol (2020-02-19)

Starting date:

February 19, 2020

Posting date:

March 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72497

Last updated: 2020-03-10

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  Reason
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  Affected products

Affected Products

Atellica CH Ethyl Alcohol

Reason

Siemens Healthcare Diagnostics Inc. investigation has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. When a positive bias is observed, the magnitude is similar for both quality control and patient results. The product issue potentially affects all Atellica CH ETOH reagent lots. Based on Siemens’ internal investigation, not all laboratories are experiencing this issue. Siemens’ investigation has shown that when this issue occurs, an average positive bias of 7 mg/dl (1.5 mmol/L) with a maximum bias of 11 mg/dL (2.4 mmol/L) at an ethanol concentration of approximately 20.6 mg/dL (4.5 mmol/L) was observed by day 10 of the pack calibration interval. Samples with an ethanol concentration of approximately 200 mg/dL (43.4 mmol/L) met expected performance criteria across the 10-day pack calibration interval. Siemens is working to address this issue in a future software version.

Affected products