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