Randox Laboratories Ltd.: Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

Hazard

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Details from the source

Reason for recall: Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods. Distribution: Domestic: Nationwide Distribution. Quantity: 80,366 units (US: 242 units; OUS: 80,094 units) Lot/code info: Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.

UPC codes

05055273200966

Source

Official record: FDA (Device enforcement) ↗

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