EliA Sample Diluent

Starting date:

March 7, 2017

Posting date:

March 24, 2017

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-62798

• Reason
• Affected products

Reason

There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles in the below mentioned products and lots.  The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples.  The deformation is described as a flange or brim, located on the inside lower part of the vial opening.  The instrument malfunction due to deformed bottles could cause erroneous test results, mainly false positive, with regard to all Elia assays, and mainly falsely increased test results for ImmunoCAP Total IgE and ImmunoCAP IgG4/IgG assays.  The frequency of this bottle defect is very low and not every defective bottle will cause the error.  An instrument malfunction caused by deformed bottles will generate the instrument error message "3-145 right arm liquid detection below lower limit with target 2".  It is important that you review your records for the above mentioned error message.

Affected products