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 is recalling ST-AIA PACK Fer assays because the medication Strensiq can cause inaccurate test results.
Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.
Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK LH II assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test results.
Tosoh Bioscience is recalling ST-AIA PACK TT3 thyroid assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.
Tosoh Bioscience is recalling ST-AIA PACK Estradiol assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate 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 Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.
Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.