Utak Laboratories Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Utak Laboratories Inc
Lot Codes / Batch Numbers
Lot C2540
Products Sold
Lot C2540
Utak Laboratories Inc is recalling Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LA due to The product has an incorrect reference value for cadmium and an incorrect expected range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product has an incorrect reference value for cadmium and an incorrect expected range.
Recommended Action
Per FDA guidance
The recalling firm issued a recall letter dated 3/19/2020 via email on 3/20/2020 requesting customers to destroy the incorrect IFU and replace it with the revised IFU.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026