FDA Device recall Z-2030-2021
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
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of 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… by The Binding Site Group, citing the high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2030-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-20 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | The Binding Site Group |
| Distribution | US |
Product
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Reason
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Identifiers
| code_info | Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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 - 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 - The Optilite Clinical Chemistry Analyzer
FDA Device · Class II · 2020-05-27 · The Binding Site Group
All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2030-2021%22
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