FDA recall Z-2407-2020

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-03-20

Report date

2020-07-01

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2407-2020