FDA (Devices) recall action 77245
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.
The Access immunoassays are susceptible to biotin interference.
The agency’s own wording, quoted from the enforcement report.
Beckman Coulter is recalling Access System-Free T4 Assay kits because they are susceptible to biotin interference, which may affect test results.
Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.
Beckman Coulter is recalling Access Total T3 immunoassays because they are susceptible to biotin interference, which may affect test results.
Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.