Recall Z-1301-2018 ยท JZG System, Test, Beta-2-Microglobulin Immunological
The Binding Site Group, Ltd.
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney d
| Date | Mar 9, 2018 |
| Status | Terminated |
| Reason | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018. |
| Quantity | 20 kits distributed to the U.S. |
| Distribution | US Distribution was made to CA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd., Aug 30, 2012 |