Recall Z-0970-2018 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
| Date | Aug 11, 2017 |
| Status | Terminated |
| Reason | The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. |
| Root cause | Device Design |
| Action | On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com |
| Quantity | 199 Kits |
| Distribution | Distribution US nationwide. |
| 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 |