ID- Fungal Antibody System - Histoplasma (2019-11-06)

Starting date:

November 6, 2019

Posting date:

November 29, 2019

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-71742

Last updated: 2019-12-02

• Reason
• Affected products

Affected Products

ID- Fungal Antibody System - Histoplasma

Reason

Based on post market surveillance activities, our raw material supplier noticed that Cat # 14011 - Histoplasma ID Antigen, Lot # L106909 was giving false positive results when compared to a previous lot of Cat # 14011. As a precautionary measure,we want to recall this product.

Affected products