Health product recall

Panther Fusion Extraction Reagent - S (2019-10-11)

Starting date:
October 11, 2019
Posting date:
November 1, 2019
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-71471



Last updated: 2019-11-01

Affected products

Panther Fusion Extraction Reagent - S

Reason

Use of this kit may give false positive and/or false negative results or failed controls leading to invalid runs.

Affected products

Panther Fusion Extraction Reagent - S

Lot or serial number

100152 (Kit)

257472 (Sub-component FCR-S)

Model or catalog number

ALTERNATE PART NUMBER: ASY-09809

PRD-04331

Companies
Manufacturer

Hologic, Inc.

10210 Genetic Drive

San Diego

92121

California

UNITED STATES