Recall Z-2407-2020
Utak Laboratories Inc · initiated March 20, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot C2540
Reason for recall
The product has an incorrect reference value for cadmium and an incorrect expected range.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-2407-2020
- Initiated
- March 20, 2020
- Terminated
- July 22, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 1,395 vials
- Distribution
- Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
- Recalling firm
- Utak Laboratories Inc, Valencia, CA