Randox Laboratories, Limited recalls Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Recall date

June 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2207-2019

FDA classification

Class III

Brand / firm

Randox Laboratories, Limited

Sold / distributed

Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

Why it was recalled

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Assayed Bovine Multi-Sera Level 1, Model No. AL1027