Device 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.
Z-2407-2020
Product summary
- Event
- Event 85660
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,395 vials
- Official record key
device-enforcement:Z-2407-2020
Official wording
Reason: The product has an incorrect reference value for cadmium and an incorrect expected range.
Code information: Lot C2540
Distribution pattern: Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
Derived failure modes
-
Unknown
The product has an incorrect reference value for cadmium and an incorrect expected range.