FDA (Devices) recall action 82521
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
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 Healthcare Diagnostics is recalling 114 Atellica IM aTG test kits because they show positive bias compared to WHO standards.
Siemens Healthcare Diagnostics is recalling 1,489 Atellica IM aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.