Valencia, CA, United States
Utak Laboratories Inc recalls
1 recall recorded since 2018, most recently on 20 March 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 20 March 2020
- Terminated
- 22 July 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2407-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.