Recall Z-0274-2022 ยท DEH Lambda, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
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
| Date | Oct 15, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/15/2021 (revised letter 10/25/2021), the firm sent an "Urgent Medical Device Correction" Notification to customers via email to inform them that it has identified an imprecision at top of calibration curve, where the calibration curves produced using specific lots have a higher activity than routinely expected and that there may be a decrease separation between calibrator point 5 and 6 which can be exacerbated when calibrator 6 activity reaches the optical ceiling of the analyzer and may result in an inaccurate value being reported. Customers are instructed to: Adapt the calibration cur |
| Quantity | 2,254 kits |
| Distribution | U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140396 | FREELITE HUMAN LAMBDA FREE KIT The Binding Site Group , Ltd., Apr 16, 2014 |