FDA Device recall Z-2407-2020
Utak NR Trace Elements Serum Control, 5 ml, REF 66816
- FDA Device
- Class III
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class III recall of Utak NR Trace Elements Serum Control, 5 ml, REF 66816 by Utak Laboratories, citing the product has an incorrect reference value for cadmium and an incorrect expected range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2407-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-03-20 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Utak Laboratories |
| Distribution | US |
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
The product has an incorrect reference value for cadmium and an incorrect expected range.
Identifiers
| code_info | Lot C2540 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2407-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.