SP CAL — Class II medical device recall Z-0660-2019
Terminated recall by Randox Laboratories Ltd., reported 2019-01-02, distributed in IN, NJ, NY, TX, WV. Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG
| Recall number | Z-0660-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2018-11-19 |
| Classified | 2018-12-21 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2020-04-23 |
| Distributed | IN, NJ, NY, TX, WV |
| Countries outside the US | IE |
| UPC / GTIN / UDI-DI | 05055273204049 |
| Lot numbers | 415879 |
| Model numbers | IT2692 |
| Expiration dates | 2019-03-28 |
Product
SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Reason for recall
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
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-0660-2019. 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.