Class III — Utak Laboratories Inc
| Recalling firm | UTAK LABORATORIES, I |
|---|---|
| Registered facility | UTAK LABORATORIES, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The product has an incorrect reference value for cadmium and an incorrect expected range. |
| Product | 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. |
| Quantity | 1,395 vials |
| Distribution | Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom. |
| Initiated | 2020-03-20 |
| Classified | 2020-06-22 |
| Terminated | 2020-07-22 |
| Recall number | Z-2407-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Utak Laboratories Inc (Z-2407-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85660/
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