Recall Z-0410-2019 ยท MRG System, Test, Vitamin D
R & D Systems, Inc.
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
| Date | Sep 11, 2018 |
| Status | Terminated |
| Reason | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm contacted the consignees (end users) by telephone on 09/11/2018 to alert them of the issue. The firm followed with an email on 09/21/2018 restating the issue and offering to replace any unused kits. |
| Quantity | 8 kits |
| Distribution | IA and CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123364 | 25OH VITAMIN D TOTAL ELISA TEST Diasource Immunoassays, S.A., Jul 15, 2013 |