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Illumigene Malaria (Kit)
- Starting date:
- July 21, 2017
- Posting date:
- August 15, 2017
- 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-64236
Reason
Meridian has discovered that the sample preparation Apparatus IV, is susceptible to evaporation over the shelf life causing low volume of the liquid reagent. Post market studies indicate that this component may not be stable through the labeled expiration dating due to this evaporation. Internal testing has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.
Affected products
Illumigene Malaria
Lot or serial number
280925H009
280925H010
280925J012
Model or catalog number
280925
Companies
- Manufacturer
-
Meridian Bioscience Inc.
3471 RIVER HILLS DRIVE
Cincinnati
45244
Ohio
UNITED STATES