Randox Cholesterol- For the quantitative in vitro determination of… — Class II medical device recall Z-1424-2022
Terminated recall by Randox Laboratories Ltd., reported 2022-07-27, distributed nationwide. Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using
| Recall number | Z-1424-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-06-22 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-05-10 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| UPC / GTIN / UDI-DI | 05055273201130 |
| Lot numbers | 28TH, 586177 |
| Model numbers | CH2O0 |
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Reason for recall
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
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-1424-2022. 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.