Randox Laboratories, Limited

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

randox laboratories limited, randox laboratories, limited

Recent Recalls

NumberClassProductDate
Z-1017-2025Class IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automatedDecember 20, 2024
Z-1018-2025Class IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated December 20, 2024
Z-1349-2020Class IIRX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - ProducDecember 19, 2019
Z-0413-2020Class IIRandox Liquid Cardiac Controls Catalogue Number CQ5052.October 4, 2019
Z-0414-2020Class IIRandox Liquid Cardiac Controls Catalogue Numbers CQ5053.October 4, 2019
Z-0412-2020Class IIRandox Liquid Cardiac Controls Catalogue Number CQ5051October 4, 2019
Z-0367-2020Class IIIRANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.September 23, 2019
Z-2083-2019Class IIRX Daytona, Model Nos. RX4040 and RX4041June 24, 2019
Z-2084-2019Class IIRX Imola, Model Nos. RX4900June 24, 2019
Z-2150-2019Class IIHuman Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for iJune 11, 2019
Z-2207-2019Class IIIAssayed Bovine Multi-Sera Level 1, Model No. AL1027June 10, 2019
Z-0937-2018Class IILiquid Cardiac Control CQ5053August 8, 2017
Z-0725-2017Class IIMagnesium on RX Imola analyser IVDApril 14, 2016