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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBeckman Coulter Recalls Uric Acid Reagent Due to Drug Interference
FDA (Devices) · 2017-05-24
- ModerateAMS Uric Acid Test Kits Recalled for Regulatory Violations
FDA (Devices) · 2014-04-02
- ModerateTranexamic Acid tablets recalled due to failed specification testing
FDA (Drugs) · 2023-06-21
- ModerateSagent Recalls Ketorolac Tromethamine Injection Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2014-10-22
- ModerateAMS BUN Urea Nitrogen Kits Recalled for Marketing Violations
FDA (Devices) · 2014-04-02
- ModerateBeckman Coulter Uric Acid Assay Recalled Due to NAC Interference
FDA (Devices) · 2015-02-04