Medical device recalls

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

Recall date
March 20, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2407-2020
FDA classification
Class III
Brand / firm
Utak Laboratories Inc
Sold / distributed
Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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