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Health product recall

GenoType MTBDR plus (2014-09-04)

Starting date:
September 4, 2014
Posting date:
September 25, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41521

Recalled products

  1. GenoType MTBDR plus

Reason

Sale and advertisement of the unlicensed medical device GenoType MTBDR plus version 2.0 kit from Hain Lifescience GmbH.

Affected products

A. GenoType MTBDR plus

Lot or serial number
  • VERSION 2.0
Model or catalog number
  • 30496A
  • 304A
Companies
Manufacturer
Hain Lifescience GmbH,
Hardwiesenstr 1,
Nehren
72147
GERMANY