Utak NR Trace Elements Serum Control — Class III medical device recall Z-2407-2020
Terminated recall by Utak Laboratories Inc, reported 2020-07-01, distributed nationwide. The product has an incorrect reference value for cadmium and an incorrect expected range.
| Recall number | Z-2407-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Utak Laboratories Inc, Valencia, CA, United States |
| Recall initiated | 2020-03-20 |
| Classified | 2020-06-22 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, FR, GB, IL, IT, NZ, PH |
| Quantity | 1,395 vials |
| Reason classes | chemical contamination |
| Lot numbers | C2540 |
| Model numbers | 66816 |
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.
Reason for recall
The product has an incorrect reference value for cadmium and an incorrect expected range.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2407-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.