Recall Z-0674-2019 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Tosoh Bioscience Inc
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
| Date | Nov 30, 2018 |
| Status | Terminated |
| Reason | |
| Root cause | Device Design |
| Action | On November 30, 2018, Tosoh Bioscience issued Urgent Medical Device Recall notices to customers. Customers are advised to take the following actions: " Do not use the assays identified in notice for those patients who have recently had a fluorescein angiography procedure. For these patients, use an alternative testing method that does not use a fluorescein-based technology. " Inform medical professionals that the Tosoh AIA assays in the notice utilize a fluorescein-based technology and should not be used to test patient samples for patients who have recently undergone fluorescein angiograph |
| Quantity | 26745 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY Tosoh Medics, Inc., Dec 17, 2002 |