Health product recall

Panther Fusion SARS-CoV-2 Primer Probe Reagent (2021-04-30)

Starting date:
April 30, 2021
Posting date:
May 18, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75617



Last updated:
2021-05-18

Affected Products

Panther Fusion SARS-CoV-2 Primer Probe Reagent

Reason

Between April 12, 2021 and April 14, 2021, Hologic's Canadian importer, Accuristix, accidentally shipped to 6 customers product (2 lots of Panther Fusion SARS-CoV-2 Assay PPR Solution) that had experienced temperature excursions during shipment from Hologic to Accuristix. Risk assessments were performed by Hologic for the lots and it was concluded that they were not fit for use.  Hologic informed Accuristix on April 28, 2021 and that is when it was discovered that Accuristix had accidentally shipped the lots to customers.

Affected products

Panther Fusion SARS-CoV-2 Primer Probe Reagent

Lot or serial number

291645, 292447

Model or catalog number

PRD-06391

Companies
Manufacturer

Hologic, Inc.

10210 Genetic Drive

San Diego

92121

California

UNITED STATES