FDA Medical Device Recalls (openFDA)
Nichols Institute Diagnostics: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
- Recall number
- Z-1118-04
- Recalling firm
- Nichols Institute Diagnostics
- Product
- Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
- Status
- Terminated
- Initiated
- 2004-06-30
- Posted
- 2005-02-24
- Terminated
- 2012-02-10
- Reason
- Lower than expected results are obtained.
- Root cause
- Other
- Action
- Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.
- Quantity
- Not Applicable.
- Distribution
- Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.
- Lot, serial or model codes
- Not limited to specific lots.
- 510(k) numbers
- ["K012367"]
- PMA numbers
- not on file
- Product code
- MRG
- Firm FEI
- 2050095
- Firm city
- San Clemente
- 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