Health product recall

LINEAR ARRAY HPV (Human Papilloma Virus) Genotyping Test (2020-02-19)

Starting date:
February 19, 2020
Posting date:
March 13, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72585

Last updated: 2020-03-13

Affected Products

LINEAR ARRAY HPV (Human Papilloma Virus) Genotyping Test

Reason

Identified lots may not perform as intended and may result in false HPV DNA not detected for HPV genotype 31.

Affected products

LINEAR ARRAY HPV (Human Papilloma Virus) Genotyping Test

Lot or serial number
  • E05866
  • F02378
  • F05629
  • F25957
Model or catalog number

4391853190

Companies
Manufacturer

Roche Molecular Systems Inc.

1080 US Highway 202

Branchburg

08876

New Jersey

UNITED STATES