FDA Device recall Z-1500-2020
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 by The Binding Site Group, citing it has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abno….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1500-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-06 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | The Binding Site Group |
| Distribution | CA |
Product
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Reason
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Identifiers
| code_info | Lot 428217 (Expiry date: 30-APR-2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by The Binding Site Group
- Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXE…
FDA Device · Class II · 2026-06-17 · The Binding Site Group - 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…
FDA Device · Class II · 2021-12-01 · The Binding Site Group - FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK0…
FDA Device · Class II · 2021-07-14 · The Binding Site Group - Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Device · Class II · 2021-02-10 · The Binding Site Group - Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
FDA Device · Class II · 2020-06-03 · The Binding Site Group
All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2020%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.