Fructosamine Control 1 — Class II medical device recall Z-1017-2019
Ongoing recall by Randox Laboratories Ltd., reported 2019-03-27, distributed in CA, ME, MI, WV. The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3
| Recall number | Z-1017-2019 |
|---|---|
| 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 | 2018-12-03 |
| Classified | 2019-03-15 |
| Reported by FDA | 2019-03-27 |
| Distributed | CA, ME, MI, WV |
| Quantity | 141 kits |
Product
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Reason for recall
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
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-1017-2019. 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.