This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Cobas Polymerised Chain Reaction (PCR) Urine Kit (2013-12-06)
- Starting date:
- December 6, 2013
- Posting date:
- March 18, 2014
- 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-38255
Recalled Products
Cobas Polymerised Chain Reaction (PCR) Urine Kit
Reason
Manufacturer has identified through customer complaints a potential for leaking of Cobas Polymerised Chain Reaction(PCR) Media included in different kit lots of Cobas PCR Urine kits and Cobas PCR Female Swab Sample kits.
Affected products
Cobas Polymerised Chain Reaction (PCR) Urine Kit
Lot or serial number
All lots
Model or catalog number
05170516190
Companies
- Manufacturer
-
Roche Molecular Systems, Inc.
1080 US Highway 202
Branchburg
08876
New Jersey
UNITED STATES
Cobas PCR Urine Kit (2013-12-06)
Lot or serial number
All lots
Model or catalog number
05170486190
Companies
- Manufacturer
-
Roche Molecular Systems, Inc.
1080 US Highway 202
Branchburg
08876
New Jersey
UNITED STATES