ADVIA CENTAUR SYSTEM AND CP SYSTEM - CALIBRATORS (2016-08-09)

Starting date:

August 9, 2016

Posting date:

August 19, 2016

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-59892

• Reason
• Affected products

Affected products

1. ADVIA CENTAUR CP SYSTEM - CALIBRATORS
2. ADVIA CENTAUR SYSTEM - CALIBRATORS

Reason

Siemens Healthcare Diagnostics has confirmed that the ADVIA Centaur systems myoglobin assay is not meeting the analytical sensitivity claim of < 3 ng/ml (ug/l) as specified in the ADVIA Centaur myoglobin instructions for use (IFU), for all in-date reagent lots when evaluated with calibrator U kit lots ending in 63 and 64. Values up to 12 ng/ml (ug/l) were observed.
Siemens' investigation has identified that the calibrator U kit lots ending in 63 or 64 have drifted from the internal standardization causing a positive shift in results.

Affected products