Recall Z-0905-2023 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
| Date | Jan 5, 2023 (initiated Nov 22, 2022) |
| Status | Open, Classified |
| Reason | Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range |
| Root cause | Under Investigation by firm |
| Action | Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to technical.s |
| Quantity | 49 units US |
| Distribution | US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972608 | RANDOX ASSAYED SPECIFIC PROTEIN CONTROL Randox Laboratories, Ltd., Aug 4, 1997 |