Recall Z-0671-2019 ยท CDD Radioassay, Vitamin B12
Tosoh Bioscience Inc
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
| Date | Nov 30, 2018 |
| Status | Terminated |
| Reason | Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays |
| 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 | 29645 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964348 | AIA-PACK B12 ASSAY Tosoh Medics, Inc., Jan 13, 1997 |