Recall Z-0762-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories
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 chemist
| Date | Sep 16, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 2817 |
| Distribution | Worldwide Distribution - US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 Randox Laboratories Limited, Jan 23, 2012 |