Home / Recalls / Randox Laboratories, Limited / Z-2207-2019

Z-2207-2019 Class III Terminated

Recalled by Randox Laboratories, Limited — Crumlin, N/A

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 10, 2019
Termination Date
June 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 kits (US)

Product Description

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

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.

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.

Code Information

205SL

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