Recall Z-2110-2020 ยท DHR System, Test, Rheumatoid Factor
The Binding Site Group, Ltd.
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
| Date | Oct 7, 2019 |
| Status | Terminated |
| Reason | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment. |
| Root cause | Process control |
| Action | The field safety notice was issued from the firm's UK office to their US office. The US office notified affected end users in the US via Field Safety Notice, dated 09 October 2019 that was sent via email on 9 Oct 2019. The FSN stated the following: 1) That it has been identified that the assigned Rheumatoid Factor (RF) calibrator value, for LK151.0PT.A lot 428224, over recovers by 7% in comparison to the reference material RF serum, NIBSC. Ref 64/002 (WHO Standard 64/2). 2) The firm has assessed risk of this over recovery and determined that there is no clinical risk, and that the kit can |
| Quantity | 478 kits |
| Distribution | US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162263 | Optilite Rheumatoid Factor Kit The Binding Site Group , Ltd., May 3, 2017 |