CLASS III Device recall · Reported 1 Jul 2020 · FDA Enforcement Report
Utak NR Trace Elements Serum Control recalled by Utak Laboratories
Utak Laboratories is recalling Utak NR Trace Elements Serum Control, distributed nationwide in the US. The recall was initiated on 20 Mar 2020 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2407-2020
- FDA event ID
- 85660
- Recalling firm
- Utak Laboratories, Valencia, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Mar 2020
- FDA classified
- 22 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Mar 2020 | Recall initiated by company | |
| 22 Jun 2020 | Classified by FDA | +94 days |
| 1 Jul 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product has an incorrect reference value for cadmium and an incorrect expected range.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
Questions about this recall
Is Utak NR Trace Elements Serum Control recalled?
Yes. Utak Laboratories recalled Utak NR Trace Elements Serum Control on 20 Mar 2020. The recall is Class III and its status is Terminated. Recall number Z-2407-2020.
Why was it recalled?
The product has an incorrect reference value for cadmium and an incorrect expected range.
Which lots are affected?
Lot C2540
Where was it sold?
Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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