Randox Liquid Assayed Specific Protein Control — Class II medical device recall Z-2279-2018
Terminated recall by Randox Laboratories Ltd., reported 2018-07-04, distributed in CA, GA, IN, KS, ME, PR, WV. The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls incr
| Recall number | Z-2279-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2018-05-22 |
| Classified | 2018-06-22 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-11-17 |
| Distributed | CA, GA, IN, KS, ME, PR, WV |
| Countries outside the US | AE, AU, BD, BE, BR, CA, CL, CN, CO, CY, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, IE, IN, IQ, IT, JO, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SK, SV, TH, TR, UA, VN, ZA |
| Model numbers | PS2683 |
Product
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Reason for recall
The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for Multiple Myeloma through review of the ratio with free lambda chains.
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-2279-2018. 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.