Why does the lot number on a vial of HemataCHECK not exactly match the lot number listed on the package insert (assay sheet)?
Each vial is marked appropriately with the control level and lot number. The lot number printed on the vial is suffixed with a letter that designates the control level. For example, STI-518L indicates the lot is STI-518. The “L” indicates the control level is LOW. Many of the HematoCHEK kits are sold in combinations of levels such as LOW and NORMAL, or LOW, NORMAL, and HIGH. The package insert (assay sheet) is simply labeled with the lot number to provide traceability to each vial of control material that is labeled with the lot number and control level. (Source: Separation Technology, Inc.
Related Questions
- Why does the lot number on a vial of HemataCHECK not exactly match the lot number listed on the package insert (assay sheet)?
- Does it matter where a package insert is placed on a labeling piece, such as on a calendar or a brochure with a pouch?
- Does a package insert in another language also have to be submitted in English?
