CanadaThe WASPLab medical device (Copan Wasp S.R.L.) with model/catalogue number W087 and lot/serial numbers W087-0147 and W087-0148 is affected. A webapp software bug can, under specific conditions, prevent a user-selected result from overwriting the phenomatrix-suggested result, so the result transmitted to the laboratory information system (LIS) may be the phenomatrix suggestion rather than the user-selected result. Contact the manufacturer for additional information.
What's being recalled
Companies: Copan Wasp S.R.L., Via Achille Grandi, 32, Brescia, Brescia, Italy, 25125.
How to identify it
Affected products: WASPLab; Lot or serial number: W087-0147; Model or catalogue number: W087
Affected products: WASPLab; Lot or serial number: W087-0148; Model or catalogue number: W087
The hazard
Copan WASP SRL is performing a medical device product correction related to the WASPLab product. A software bug has been identified in the webapp software which, under specific conditions, may prevent the result suggested by phenomatrix from being overwritten by the result selected by the user. As a consequence, the result transmitted by WASPLab to the LIS may be the result suggested by phenomatrix, rather than the result selected
by the user.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)