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ImmunoCard Mycoplasma
- Starting date:
- October 30, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15877
Recalled Products
1. ImmunoCard Mycoplasma
Reason
Meridian has received reports from customers of invalid negative control reactions and of blue-coloured substrate reagent. As indicated in the product package insert, substrate reagent should be colourless. Substrate reagent exhibiting a blue colour should be discarded. Preliminary investigation indicates that the invlaid negative control reactions are attributable to the blue substrate reagent (lot 7801.486). The remaining kit components and reagents are meeting performance specifications.
Affected products
1. ImmunoCard Mycoplasma
Lot or serial number
709030C714, 709030C713
Model or catalog number
709030
Companies
- Manufacturer
- Meridian Bioscience Inc.