Liquid Protein Calibrators — Class II medical device recall Z-1328-2024
Ongoing recall by Randox Laboratories Ltd., reported 2024-03-27, distributed in CA, FL, IL, ME, NJ, OH, OR. The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA4
| Recall number | Z-1328-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2024-03-01 |
| Classified | 2024-03-20 |
| Reported by FDA | 2024-03-27 |
| Distributed | CA, FL, IL, ME, NJ, OH, OR |
| Quantity | 1,764 units |
| UPC / GTIN / UDI-DI | 05055273204032 |
| Lot numbers | 627222/2112IT-2116IT, 627224/2112IT-2116IT, 634886/2112IT-2116IT, 634887/2112IT-2116IT, 647342/2154IT-2158IT, 647343/2154IT-2158IT |
| Model numbers | IT2691 |
Product
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Reason for recall
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
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-1328-2024. 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.