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Recall Observatory FDA recall evidence

Device 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.

Z-2407-2020

March 20, 2020

Class III

Product summary

Firm
Utak Laboratories Inc
Event
Event 85660
Status
Terminated
Classification
Class III
Quantity
1,395 vials
Official record key
device-enforcement:Z-2407-2020

Official wording

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

Code information: Lot C2540

Distribution pattern: Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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