FDA (Devices) recall action 84078
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Homocysteine Assay May Cause Elevated Results in the Folate Assay
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.
Siemens is recalling ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.
Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.
Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate results.