VYSIS PARAFFIN PRETREATMENT KIT (2017-10-26)

Starting date:

October 26, 2017

Posting date:

November 10, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-65070

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  Reason
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  Affected products

Affected products

VYSIS PARAFFIN PRETREATMENT KIT

Reason

It was recently identified that some Vysis Paraffin Pretreatment Reagent Kits may have been distributed with an incorrect lot number printed on the packaging labeling. The kit lot number appears in three places on the Vysis Paraffin Pretreatment Reagent Kits:

1. The Abbott molecular Certificate of Analysis that is packed within each kit,

2. The label which is placed on the kit carton, and

3. The label which is placed on the outer sleeve that goes over the kit carton.

The correct lot number is 2087c172 and it is correctly printed on the Certificate of Analysis that is packaged within each kit. Although unlikely, an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.

Affected products