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FDA (Device enforcement)Recalled 2022-11-22class ii

Randox Laboratories Ltd.: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

Hazard

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Details from the source

Reason for recall: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range Distribution: US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN. Quantity: 115 units Lot/code info: GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24

UPC codes

05055273204902

Source

Official record: FDA (Device enforcement)

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

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