Utak Trace Elements Serum Control Recalled for Incorrect Reference Values
Utak Laboratories is recalling 1,395 vials of NR Trace Elements Serum Control due to incorrect cadmium reference values and expected ranges.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a labeling error regarding reference values rather than a direct physical hazard.
Plain-English summary
Utak Laboratories, Inc. is recalling 1,395 vials of Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The product is a control used for in vitro diagnostics. The recall is due to an incorrect reference value for cadmium and an incorrect expected range.
The affected product is Lot C2540. It was distributed worldwide, including in the United States, Canada, Australia, France, Germany, Israel, Italy, New Zealand, the Philippines, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected product and contact Utak Laboratories for further instructions.
The recalled product
- 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.
- Manufacturer
- Utak Laboratories Inc
- Hazard
- Affected units
- 1,395
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot C2540
Distribution
Distributed nationwide across the United States.
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