ADVIA Centaur and ADVIA Centaur CP (2018-12-10)

Starting date:

December 10, 2018

Posting date:

January 8, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68694

• 
  Reason
• 
  Affected products

Affected products

1. ADVIA Centaur
2. ADVIA Centaur CP

Reason

Siemens identified a positive bias with ADVIA Centaur aTG Kit lots ending in 316 and lower when compared to the standardization to world health organization (who) reference preparation MRC 65/93 stated in the Instructions For Use (IFU).

Traceability to who reference preparation MRC 65/93 is restored with the release of ADVIA Centaur aTG kit lots ending in 318 and higher (available in December 2018). As stated in the IFU, the theoretical who international units (IU/ml) is on average 3-fold higher than Siemens healthcare diagnostics standardization. Moving forward, this traceability will be maintained through enhancements to the control system.

Customers will observe a negative shift in patient results when transitioning from ADVIA Centaur aTG reagent kit lots 316 and lower to ADVIA centaur aTG reagent kit lots 318 and higher.

Affected products