NucliSENS Easymag Lysis Buffer (2014-03-06)

Starting date:

March 6, 2014

Posting date:

April 4, 2014

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-38791

• Reason
• Affected products

Recalled Products

Nuclisens Easymag Lysis Buffer

Reason

The risk to use the product beyond the expiration date due to the incorrect label is to have false results. The severity level of the risk to obtain false results (due to the insufficient extraction) has been assessed as critical considering that the product is used in the extraction phase of the NucliSENS and r-gene tests and it is also used, always in the extraction phase, in association with other kits not manufactured by biomerieux. Medical affairs confirmed the severity of the issue as critical for adverse health consequences and mitigated the occurrence as remote (unlikely to occur, but is possible).

Affected products