Optilite Optilite Rheumatoid Factor Kit — Class II medical device recall Z-2110-2020
Terminated recall by The Binding Site Group, Ltd., reported 2020-06-03, distributed in AL, AR, AZ, FL, GA, KY, MA, MD…. Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the d
| Recall number | Z-2110-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2019-10-07 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-01-11 |
| Distributed | AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI |
| Quantity | 478 kits |
| UPC / GTIN / UDI-DI | 05051700020015 |
| Lot numbers | 428224 |
| Model numbers | LK151.OPT.A |
Product
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2110-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.