Z-2407-2020 Class III Terminated
FDA device recall Z-2407-2020 was initiated by Utak Laboratories Inc on March 20, 2020 and is designated Class III. Reason for recall: The product has an incorrect reference value for cadmium and an incorrect expected range. The recall status is terminated (terminated July 22, 2020). Affected quantity: 1,395 vials.
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