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Cobas 4800 Sample Preparation Kit
- Starting date:
- November 22, 2016
- Posting date:
- December 13, 2016
- 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-61430
Reason
Recall related to a change in the package insert of the Cobas 4800 HPV amplification/detection kits. Following review of additional data, it was confirmed that all SurePath Specimens must now be pretreated prior to testing.
Affected products
Cobas 4800 Sample Preparation Kit
Lot or serial number
All lots
Model or catalog number
- 05235782190
- 05235804190
Companies
- Manufacturer
-
Roche Molecular Systems Inc.
1080 US Highway 202
Branchburg
08876
UNITED STATES