Z-2575-2018 Class II Terminated
FDA device recall Z-2575-2018 was initiated by Randox Laboratories Ltd. on Jun 8, 2018 and is designated Class II. Reason for recall: The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range… The recall status is terminated (terminated Nov 5, 2018). Affected quantity: 1 kit (US), 602 kits (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 8, 2018
- Initiation Date
- Jun 8, 2018
- Termination Date
- Nov 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit (US), 602 kits (OUS)
Product Description
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
Reason for Recall
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
Distribution Pattern
Worldwide Distribution - US in the state of WV. Foreign distribution to Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam
Code Information
Lot 4245CK.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2575-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026