Randox Laboratories Ltd.: Calibration Serum Level 3 CAL2351

Hazard

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

Details from the source

Reason for recall: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%. Distribution: US Nationwide and Puerto Rico. Quantity: 269 kits Lot/code info: GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE

UPC codes

05055273200966

Source

Official record: FDA (Device enforcement) ↗

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