Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Assayed Bovine Multi-Sera Level 1 Recalled by Randox Laboratories, Limited Due to The firm is re-assigning the Mean of all...

Date: June 10, 2019
Company: Randox Laboratories, Limited
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories, Limited directly.

Affected Products

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

Quantity: 4 kits (US)

Why Was This 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.

Where Was This Sold?

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.

About Randox Laboratories, Limited

Randox Laboratories, Limited has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report