Advia Centaur, Centaur CP, and Centaur XP Systems - Folate Assays (2014-03-26)

Starting date:

March 26, 2014

Posting date:

April 14, 2014

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-39035

• 
  Reason
• 
  Affected products

Recalled Products

1. Advia Centaur CP System - Folate (FOL) Assay
2. Advia Centaur XP System - Folate (FOL) Assay
3. Advia Centaur System - Folate Assay

Reason

Siemens confirmed one set of complaints with the Advia Centaur systems folate, kit lots ending in 223. Customers observed that the Bio-Rad Liquichek and Lyphochek Folate serum controls may go out of range low with Advia Centaur systems folate kit lots ending in 223. Whole blood controls with Advia Centaur folate reagent kit lots ending in 223 are within range and whole blood patients are consistent with previous reagent lots. In addition, Siemens has confirmed a second set of customer complaints regarding a shift in whole blood patients when moving from Advia Centaur systems folate kit lots ending in 219 to kit lots ending in 222,224, 225, 226 and/or 227. Siemens performed a whole blood normal range study that shows kit lots ending in 219 do not demonstrate a normal range pattern shown in the instructions for use (IFU). Serum controls and patients show normal lot to lot variation with all in date lots of folate reagents.

Affected products