Z-0382-2019 Class II Terminated
FDA device recall Z-0382-2019 was initiated by Randox Laboratories Ltd. on Oct 2, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 30, 2019). Affected quantity: 2108.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Oct 2, 2018
- Termination Date
- May 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2108
Product Description
Liquid Cardiac Control, CQ5053
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0382-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026