FDA Device recall Z-1053-2017
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple M…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple M… by The Binding Site Group, citing A change in the calibration curve causing an increase in false prozone flags.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1053-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-28 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | US |
Product
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
Reason
A change in the calibration curve causing an increase in false prozone flags.
Identifiers
| code_info | Lot #400012, 400257 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1053-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.