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EBV Antibody Test Kits (2016-02-05)
- Starting date:
- February 5, 2016
- Posting date:
- February 22, 2016
- 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-57198
Affected Products
- EBV IGM TEST KIT
- EBV IGG TEST KIT
- EBV-NA TEST KIT
Reason
The foil pouches for some EBV-NA (EN100) substrate slides appear to have been damaged, resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. Meridian's investigation has also determined that the desiccant packaged with the compromised EBV-NA substrate slides have turned pink, indicating exposure to moisture. The desiccants are typically blue.
Affected products
-
EBV IGM TEST KIT
Lot or serial number
EB150G160
Model or catalog number
EB150
Companies
- Manufacturer
-
Meridian Bioscience Inc.
3471 RIVER HILLS DRIVE
Cincinnati
45244
Ohio
UNITED STATES
B. EBV IGG TEST KIT
Lot or serial number
EB100180
Model or catalog number
EB100
Companies
- Manufacturer
-
Meridian Bioscience Inc.
3471 RIVER HILLS DRIVE
Cincinnati
45244
Ohio
UNITED STATES
C. EBV-NA TEST KIT
Lot or serial number
EN100G190
Model or catalog number
EN100
Companies
- Manufacturer
-
Meridian Bioscience Inc.
3471 RIVER HILLS DRIVE
Cincinnati
45244
Ohio
UNITED STATES