FDA-Device2020-07-01Class III
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.
Utak Laboratories Inc
Hazard
The product has an incorrect reference value for cadmium and an incorrect expected range.
Sold states
Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
Affected count
1,395 vials
Manufactured in
25020 Avenue Tibbitts, N/A, Valencia, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2407-2020Don't want to check this manually?
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