CMV IGM for ELECSYS and COBAS E and Diluent Universal (2015-02-18)

Starting date:

February 18, 2015

Posting date:

March 5, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-52463

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  Reason
• 
  Affected products

Recalled Products

A. CMV IGM for ELECSYS and COBAS E

B. Diluent Universal

Reason

This recall is related to a potential reduction in the signal of the Elecsys CMV IGM assay when used in combination with some specific Lots of Diluent Universal which may lead to false negative results for patients samples with high reactivity against one specific antigen. This may be affected by reduced cut-off values which may lead to a false negative result when the affected combination is used. The signal reduction has only minor effects on the calibrators and controls.

Affected products