FDA (Devices) recall action 70470
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.
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
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 Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.
Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.