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Anti-DS DNA Kit (2014-12-18)
- Starting date:
- December 18, 2014
- Posting date:
- May 21, 2015
- 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-53421
Recalled Products
A. Anti-DS DNA Kit
Reason
Specific product codes for the Anti-dsDNA kit were omitted in error. This means that customers have received the correct products, due to the omission of the product code on the outer box, it is not clearly identifiable if they have received the 50 tests version (IM77 lot C323026) or 100 tests version (IM771 lot C323027). The kits may be differentiated by the lot numbers printed on the outer box. The individual component labelling within the kit has not been affected. Also, the tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product.
Affected products
A. Anti-DS DNA Kit
Lot or serial number
C323027
Model or catalog number
IM771
Companies
- Manufacturer
-
Trinity Biotech PLC
IDA Business Park
Bray, Wicklow
IRELAND