RANDOX CHOL-cholesterol — Class II medical device recall Z-0328-2022
Terminated recall by Randox Laboratories Ltd., reported 2021-12-08, distributed nationwide. When calibrating using the standard provided in the kit, the change in absorbance is lower than expected gener
| Recall number | Z-0328-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2021-11-01 |
| Classified | 2021-12-01 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2023-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| UPC / GTIN / UDI-DI | 05055273201130 |
| Lot numbers | 28TH, 559344, 572730 |
| Model numbers | CH200 |
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Reason for recall
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high 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-0328-2022. 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.