Reported Jul 1, 2020 · Terminated

Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC.,…

Utak Laboratories Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Utak Laboratories Inc · 25020 Avenue Tibbitts · Valencia, CA · 91355-3447

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot C2540
Amount recalled
1,395 vials

Where it was sold

  • Nationwide

Why it was recalled

The product has an incorrect reference value for cadmium and an incorrect expected range.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 22, 2020 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.