Randox Laboratories Ltd.: Medical Device Recalls in 2018

According to to data from the FDA, there were 9 medical device recalls made by Randox Laboratories Ltd. in 2018. See the details of the recalls below.

You can see similar recalls for other firms.

• Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
• Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
• Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
• Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
• Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
• Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
• Liquid Cardiac Control, CQ5051
• Liquid Cardiac Control, CQ5052
• Liquid Cardiac Control, CQ5053