FDA Medical Device Recalls (openFDA)
Utak Laboratories Inc: 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.
- Recall number
- Z-2407-2020
- Recalling firm
- Utak Laboratories Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-03-20
- Posted
- not on file
- Terminated
- 2020-07-22
- Reason
- The product has an incorrect reference value for cadmium and an incorrect expected range.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- 1,395 vials
- Distribution
- Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.
- Lot, serial or model codes
- Lot C2540
- 510(k) numbers
- ["K883147"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 2022375
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28