Food, drugs, devices › The Binding Site Group, Ltd.
Device recall: Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPL
FDA enforcement event 88921 is a device recall by The Binding Site Group, Ltd. of Birmingham, initiated 15 Oct 2021 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. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 4 Feb 2025. 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
"Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer."
Distribution
"U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0274-2022 | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S | 2,254 kits | Class II | Terminated | 1 Dec 2021 |
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: "Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer."
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.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Feb 2025. "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.