FDA (Devices) recall action 79813
The FDA (Devices) publishes a recall like this one as 35 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 35 pages.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the 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.
Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.
Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA PACK Fer assays because the medication Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK BMG tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.