Panther Fusion® Gbs Assay

Panther Fusion® GBS Assay Recall Summary The Panther Fusion® GBS Assay, a diagnostic test used to detect group B streptococcus (GBS) bacteria, is being recalled across Canada due to performance issues with the test. This Class I recall affects anyone in Canada who may have received results from this assay. The test is manufactured for clinical use in healthcare settings.

Product

Panther Fusion® GBS Assay

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2024-12-30

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cc2b17e9-7fc6-43d3-9202-ccdd876c8453