The Binding Site Group, Ltd. Recall 88921
Description: 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
The Binding Site Group, Ltd. Recall 88921 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0274-2022 |
| Event ID | 88921 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada |
| Quantity | 2,254 kits |
| Recall 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. |
| Device Classification | 20211201 |
| Device Code Info | Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664 |
| Center Classification Date | 20211119 |
| Recall Initiation Date | 20211015 |
| Recalling Firm | The Binding Site Group, Ltd. |
| Initial Notification | Letter |
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