SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. is recalling SP CAL (LIQ), REF IT2692, a calibrator product used with various Randox diagnostic assays. The recall affects 250 kits (32 in the US and 218 internationally) with lot number 415879 and expiration date of March 28, 2019. The product was distributed in the US states of Indiana, New Jersey, New York, Texas, and West Virginia, as well as internationally to Ireland.
The reason for the recall is that calibrator value sheets were modified to correct assigned values for Alpha-1-Acid-Glycoprotein (AGP), IgA, and IgG to improve alignment, and the IgG measurement reference was also corrected. The source does not specify a remedy or required consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Reason for recall: Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. Distribution: US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland. Quantity: 250 kits (32 kits US / 218 kits OUS) Lot/code info: 05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.