Panther Fusion Tube Trays, FAB-15004 (2020-08-04)

Starting date:

August 4, 2020

Posting date:

September 25, 2020

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-73987

Last updated:
2020-09-25

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  Reason
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  Affected products

Affected Products

Panther Fusion Tube Trays, FAB-15004

Reason

There is a low risk of leaking with these trays, which potentially could invalidate patient results or assay worklists, causing delayed results for any Panther Fusion assays with which they are used.  Additionally, there is an unlikely possibility that the affected Panther Fusion tube trays may cause a false negative result with the Panther Fusion Flu A/B/RSV assay or the Panther Fusion Paraflu assay.

Affected products