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

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  Reason
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  Affected products

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