Recall Z-0937-2018 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories, Limited
Liquid Cardiac Control CQ5053
| Date | Aug 8, 2017 |
| Status | Terminated |
| Reason | Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field. |
| Root cause | Unknown/Undetermined by firm |
| Action | A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction. |
| Quantity | 450 kits |
| Distribution | Nationally |
| 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 |