Recall Z-1500-2020 ยท DHR System, Test, Rheumatoid Factor
The Binding Site Group, Ltd.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
| Date | Nov 6, 2019 |
| Status | Terminated |
| Reason | It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing. |
| Root cause | Nonconforming Material/Component |
| Action | It has been identified that the Rheumatoid Factor calibrator values, for LK151.S.A lot 428217, over recover in comparison to the reference material RF serum, NIBSC. To address this, the calibrator concentration values for the calibrators (SC151.A - E lot 448765) supplied in this kit have been adjusted to align more closely with the reference material. Due to the adjustment of the calibrator values, users may observe a decrease of approximately 21% in patient results in comparison to results obtained using previous calibrator values. In the absence of adopting these changes identified in the fi |
| Quantity | 30 kits |
| Distribution | Distributed in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS The Binding Site Group , Ltd., Dec 7, 2016 |