FDA Device recall 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
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases by The Binding Site Group, citing calibration curve activity has increased over time in the kit lots listed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1050-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-28 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | AZ, CA, GA, HI, ID, MA, NY, OK, PA, TX, UT |
Product
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Reason
Calibration curve activity has increased over time in the kit lots listed.
Identifiers
| code_info | Lot #323278, 327963 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1050-2017%22
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