FDA (Devices) recall action 86238
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
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.
Randox Laboratories is recalling 143 kits of the AM1054 Ammonia reagent because it shows a positive bias of up to 140 µmol/l on patient samples.
Randox Laboratories is recalling 143 kits of AM1015 Ammonia reagents due to a positive bias of up to 140 µmol/L observed in patient samples.