Food, drugs, devices › The Binding Site Group, Ltd.
Device recall: Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma an
FDA enforcement event 76049 is a device recall by The Binding Site Group, Ltd. of Birmingham, initiated 28 Nov 2012 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 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 3 Mar 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, United Kingdom.
Reason for recall
"Calibration curve activity has increased over time in the kit lots listed."
Distribution
"U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1050-2017 | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. | 1,002 | Class II | Terminated | 25 Jan 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: "Calibration curve activity has increased over time in the kit lots listed."
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: "U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Mar 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.