Randox Laboratories, Limited: Medical Device Recall in 2019 - (Recall #: Z-2207-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 10, 2019

Date Posted: August 14, 2019

Recall Number: Z-2207-2019

Event ID: 83153

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 kits (US)

Code Information:

205SL

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated