Micro SSP DNA Typing Trays (2013-02-21)

Starting date:

February 21, 2013

Posting date:

February 10, 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-37841

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  Reason
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  Affected products

Recalled Products

Micro SSP DNA Typing Trays

Reason

Null allele information on the lot specific documents of these products is incorrect and may cause mis-assignment - refer to table 1- reaction patterns and potential mis-assignments.  The root cause investigations determined that null allele entries during nomenclature update were not verified per standard operating procedure.  No adverse events or product complaints have been received.

Affected products