Recall Z-0762-2017
Randox Laboratories · initiated September 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
Codes / lots: CQ5053 CQ5052
Reason for recall
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
FDA-determined cause: Nonconforming Material/Component
Action taken
Randox sent an Urgent Field Safety Notice dated September 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please note the control value sheets have been updated with the new values. A FSN has been completed to advise customers on the appropriate action to take. For further questions, please call (304) 728-2890.
Details
- Recall number
- Z-0762-2017
- Initiated
- September 16, 2016
- Terminated
- April 11, 2018
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 2817
- Distribution
- Worldwide Distribution - US Distribution.
- Recalling firm
- Randox Laboratories, Antrim