Recall Z-1785-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
| Date | Mar 11, 2019 |
| Status | Terminated |
| Reason | Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI. |
| Root cause | Under Investigation by firm |
| Action | On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI). Customers were asked to do the following: * Inspect your stock and quarantine affected stock. " Replace the value sheet in the kit with the revised value sheet provided. " Randox is not recommending a review of previ |
| Quantity | 11420 kits |
| Distribution | Product distributed to CA, DE, WV, and Puerto Rico. |
| 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 |