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.
Reported: July 1, 2020 Initiated: March 20, 2020 #Z-2407-2020
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.
Details
- Recalling Firm
- Utak Laboratories Inc
- Units Affected
- 1,395 vials
- Distribution
- Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
- Location
- Valencia, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Utak Laboratories Inc. Units affected: 1,395 vials.
Why was this product recalled? ▼
The product has an incorrect reference value for cadmium and an incorrect expected range.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Low. Recall number: Z-2407-2020.
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