Randox Laboratories Ltd.: RX Series Copper (Cu) Assay Ref. Number CU2340

Hazard

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Details from the source

Reason for recall: Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results. Distribution: US Nationwide distribution in the states of SC and OK. Quantity: 3,053 kits (2 US, 3,051 OUS) Lot/code info: Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;

UPC codes

05055273201949

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.