FDA (Devices) recall action 83582
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Vital Scientific N.V. is recalling four Viva-JR automated chemistry analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.
Vital Scientific N.V. is recalling five Selectra ProM Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.
Vital Scientific is recalling six Selectra ProS Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.
Vital Scientific N.V. is recalling 39 V-Twin automated chemistry analyzers due to a power supply failure that prevents the instruments from producing patient results.
Vital Scientific N.V. is recalling 75 Viva-E automated chemistry analyzers due to power supply failures that prevent the instruments from producing patient results.