FDA Device recall Z-0328-2022
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- FDA Device
- Class II
- terminated
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 by Randox Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0328-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-01 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Reason
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
Identifiers
| code_info | Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130 |
|---|
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-0328-2022%22
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