Z-2207-2019 Class III Terminated
FDA device recall Z-2207-2019 was initiated by Randox Laboratories, Limited on June 10, 2019 and is designated Class III. 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. The recall status is terminated (terminated June 16, 2020). Affected quantity: 4 kits (US).
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