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Health product recall

Clinitek Novus Automated Urine Chemistry Analyzer (with and without rack handler) (2014-11-10)

Starting date:
November 10, 2014
Posting date:
November 20, 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-42215

Recalled Products

  1. Clinitek Novus Automated Urine Chemistry Analyzer (with rack handler)
  2. Clinitek Novus Automated Urine Chemistry Analyzer (without rack handler)

Reason

Siemens healthcare diagnostics has identified a potential pinch hazard in the interior of Clinitek Novus analyzer. The potential pinch hazard is in the area of the syringe pump and is only present when the instrument is operating with the front cover open. The instrument can operate with the front cover open during the "systems sequence test" mode for troubleshooting and/or maintenance.

Affected products

A. Clinitek Novus Automated Urine Chemistry Analyzer (with rack handler)

Lot or serial number

All lots.

Model or catalog number
  • 10494134
  • 10844545
Companies
Manufacturer

Siemens Healthcare Diagnostics Manufacturing Ltd.,

Northern Road,

Sudbury, Suffolk, United Kingdom

CO10 2XQ



B. Clinitek Novus Automated Urine Chemistry Analyzer (without rack handler)

Lot or serial number

All lots

Model or catalog number
  • 10697937
  • 10844557
Companies
Manufacturer

Siemens Healthcare Diagnostics Manufacturing Ltd.,

Northern Road,

Sudbury, Suffolk, United Kingdom

CO10 2XQ