FDA Device recall Z-2110-2020
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) by The Binding Site Group, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2110-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-07 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | The Binding Site Group |
| Distribution | AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI |
Product
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
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.
Identifiers
| code_info | Kit Lot Number: 428224 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2110-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.