Liquid Assayed Specific Protein- In vitro diagnostic use — Class II medical device recall Z-0903-2023
Ongoing recall by Randox Laboratories Ltd., reported 2023-01-11, distributed nationwide. Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in report
| Recall number | Z-0903-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-11-22 |
| Classified | 2023-01-05 |
| Reported by FDA | 2023-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 146 units |
| UPC / GTIN / UDI-DI | 05055273204896 |
| Lot numbers | 28TH, 584LPC, 600LPC, 611LPC |
| Model numbers | PS2682 |
Product
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Reason for recall
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
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-0903-2023. 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.