FDA Device recall Z-2490-2019
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays
- FDA Device
- Class III
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class III recall of This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays by Randox Laboratories, citing randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2490-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-12 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Reason
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Identifiers
| code_info | Lot Numbers: 961UE onwards GTN: 05055273200966 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2490-2019%22
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