Recall Z-2168-2017 ยท JZO System, Test, Thyroid Autoantibody
Tosoh Bioscience, Inc.
AIA-PACK TPOAb CONTROL SET
| Date | May 15, 2017 (initiated Feb 8, 2017) |
| Status | Terminated |
| Reason | The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label. |
| Root cause | Labeling mix-ups |
| Action | On 3/3/2017 the firm sent recall notificaion letters to their customers. |
| Quantity | 15 boxes |
| Distribution | Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981521 | AIA-PACK TPOAB ASSAY Tosoh Medics, Inc., Oct 8, 1998 |