FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems — Class II medical device recall Z-2030-2021
Terminated recall by The Binding Site Group, Ltd., reported 2021-07-14, distributed nationwide. The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigne
| Recall number | Z-2030-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, United Kingdom |
| Recall initiated | 2021-05-20 |
| Classified | 2021-07-07 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2025-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CA, CH, CY, CZ, DE, DK, EE, EG, ES, FR, GB, HK, IL, IN, IR, IT, KR, LB, LU, MA, MY, NL, NO, OM, PL, PT, RO, SG, SI, TN, TW, VN |
| UPC / GTIN / UDI-DI | 05051700012096 |
| Lot numbers | 457890, 480133, 487719 |
| Model numbers | LK016.CB |
| Expiration dates | 2022-07-31, 2022-09-30 |
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 for recall
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2030-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.