Food, drugs, devices › The Binding Site Group, Ltd.
Device recall: Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four co
FDA enforcement event 85366 is a device recall by The Binding Site Group, Ltd. of Birmingham, N/A, initiated 7 Oct 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 11 Jan 2022. Initiation: voluntary: firm initiated. The Binding Site Group, Ltd. has 23 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom.
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."
Distribution
"US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2110-2020 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) | 478 kits | Class II | Terminated | 3 Jun 2020 |
Context
Other enforcement events for The Binding Site Group, Ltd.
All 23 events for The Binding Site Group, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.