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Diastat ANA ELISA
- Starting date:
- May 23, 2017
- Posting date:
- June 12, 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-63588
Reason
ANA200 Kit Lot TS 3577 was reworked due to shortened shelf-life. Alert sticker on the kit box informed customers of shortened shelf life and referenced a letter sent to customers where the new expiration date was stated. New expiration date was not printed on the alert sticker, but should have been. Although it has since been determined that the kit can be used throughout the original shelf-life, the product is considered to be mislabelled which is why it is being recalled. The recall does not affect patient safety.
Affected products
Diastat ANA ELISA
Lot or serial number
TS3577
Model or catalog number
FANA 200
Companies
- Manufacturer
-
Euro Diagnostica AB
Lundavagen 151
Malmo
21224
SWEDEN