Recall Z-2022-2023 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
| Date | Jun 28, 2023 (initiated May 4, 2023) |
| Status | Open, Classified |
| Reason | Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range |
| Root cause | Nonconforming Material/Component |
| Action | Randox issued via email to the Distributor Medical Device Correction Letter and forwarded to US and PR customers on 04 May, 2023. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the current IFU and download the updated IFU from randox.com Discuss the contents of this notice with your Medical Director. Complete and return the response for 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organizati |
| Quantity | 30 kits |
| Distribution | CA, IL, VA, WA, WI including PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL Randox Laboratories Limited, May 22, 2014 |