Recall Z-2407-2020— Utak Laboratories Inc

Name: FDA recall Z-2407-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-20

Class III · Terminated

Class III FDA medical device recall by Utak Laboratories Inc, initiated 2020-03-20, terminated 2020-07-22. It names one FDA 510(k) clearance: K883147. 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: The product has an incorrect reference value for cadmium and an incorrect expected range..

Recalling firm: Utak Laboratories Inc
Classification: Class III
Status: Terminated
Initiated: 2020-03-20
Terminated: 2020-07-22
Firm location: Valencia, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K883147 — TRACE ELEMENTS SERUM TOXICOLOGY CONTROLUtak Laboratories, Inc.·cleared 1988-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.