Food, drugs, devices › The Binding Site Group, Ltd.
Device recall: Optilite IgG4 Kit Product Code: LK009.OPT.A
FDA enforcement event 76131 is a device recall by The Binding Site Group, Ltd. of Birmingham, N/A, initiated 23 Dec 2016 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 3 May 2017. 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
"A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert"
Distribution
"U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1089-2017 | Optilite IgG4 Kit Product Code: LK009.OPT.A | 9 users | Class III | Terminated | 1 Feb 2017 |
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: "A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 May 2017. "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.