medical Class II Updated 2020-04-01

Randox Laboratories Ltd. recalls Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 0505527320

Recalled Product

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

Hazard / Issue

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 306UL
View official government recall

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