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NEOBASE SUCCINYLACETONE ASSAY SOLUTION (2017-11-02)
- Starting date:
- November 2, 2017
- Posting date:
- November 22, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, Hospitals, General Public
- Identification number:
- RA-65206
Affected products
NEOBASE SUCCINYLACETONE ASSAY SOLUTION
Reason
The vial and stopper used in this assay solution is provided by an external supplier. It was observed, during manufacturing of a lot, that some of the stoppers within the reagent vials were assembled incorrectly by the supplier. The seal was deformed or assembled upside down. Two of the affected vials were leaking.
Affected products
NEOBASE SUCCINYLACETONE ASSAY SOLUTION
Lot or serial number
654184
655300
Model or catalog number
3042-0020
Companies
- Manufacturer
-
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND