Z-0380-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- October 2, 2018
- Termination Date
- May 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1763
Product Description
Liquid Cardiac Control, CQ5051
Reason for Recall
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Distribution Pattern
Distributed to IN, NY, PR, and WV.
Code Information
All lots