Z-2407-2020 Class III Terminated

Recalled by Utak Laboratories Inc — Valencia, CA

Recall Details

Product Type
Devices
Report Date
July 1, 2020
Initiation Date
March 20, 2020
Termination Date
July 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,395 vials

Product Description

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 Pattern

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

Code Information

Lot C2540