FDA Device recall Z-1547-2020
Chemistry QC Premium Plus, Cat
- FDA Device
- Class II
- ongoing
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Chemistry QC Premium Plus, Cat by Randox Laboratories, citing the control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1547-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-02-18 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Reason
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Identifiers
| code_info | Lot 306UL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1547-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.