Atellica CH 930 Analyzer (2019-09-25)

Starting date:

September 25, 2019

Posting date:

October 11, 2019

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-71265

Last updated: 2019-10-11

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  Reason
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  Affected products

Affected Products

Atellica CH 930 Analyzer

Reason

Siemens Healthcare Diagnostics, INC. has confirmed that on the Atellica CH 930 Analyzer, when a reagent lot calibration and a pack calibration (C0 adjust) on the same assay are manually ordered at the same time, the reagent lot calibration recovery of the analyte is 5 times higher because the 5x predilution factor is improperly factored into the QC and patient sample result calculation. The following assays are affected: acetaminophen (ACET), cholesterol (CHOL_2), glucose oxidase (GLUO), triglycerides (TRIG), uric acid (UA), urea nitrogen (UN_C) and inorganic phosphorus (IP). If QC is ordered with calibration and C0 adjust, QC results will be out of range high (red status on the atellica solution - calibration results details screen) and the calibration will display a status of "Awaiting Acceptance". If QC is not ordered with calibration and C0 adjust, then the calibration status will be shown as "Valid". Patient results and QC results will be 5 times higher.

Affected products