Z-2407-2020Class III

Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK...

Name: Z-2407-2020 Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK...
Creator: Utak Laboratories Inc
Published: 2020-03-20
License: https://open.fda.gov/license/

Utak Laboratories Inc / initiated 2020-03-20 / Terminated / root cause: labeling and UDI

FDA source

Utak Laboratories Inc began a recall of 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... on 2020-03-20. FDA classified it as Class III and gives the reason as "The product has an incorrect reference value for cadmium and an incorrect expected range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2407-2020
Classification: Class III
Status: Terminated
Initiated: 2020-03-20
Posted: 2020-06-22
Terminated: 2020-07-22
Recalling firm: Utak Laboratories Inc
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.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The product has an incorrect reference value for cadmium and an incorrect expected range.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 1,395 vials
Distribution: Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
Product codes and lots: Lot C2540

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2407-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2407-2020	Class III	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-22

Product code JJY

K883147Class ITrace Elements Serum Toxicology ControlUtak Laboratories, Inc. / cleared 1988-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)