FDA Device recall Z-1424-2022
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma by Randox Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1424-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-22 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Reason
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.
Identifiers
| code_info | GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1424-2022%22
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