Recall Z-2407-2020 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Utak Laboratories Inc
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.
| Date | Mar 20, 2020 |
| Status | Terminated |
| Reason | The product has an incorrect reference value for cadmium and an incorrect expected range. |
| Root cause | Labeling Change Control |
| Action | The recalling firm issued a recall letter dated 3/19/2020 via email on 3/20/2020 requesting customers to destroy the incorrect IFU and replace it with the revised IFU. |
| Quantity | 1,395 vials |
| Distribution | Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883147 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROL Utak Laboratories, Inc., Oct 6, 1988 |