FDA Medical Device Recalls (openFDA)
Nichols Institute Diagnostics: Nichols Advantage ACTH Test System, catalog number 62-7004.
- Recall number
- Z-1044-05
- Recalling firm
- Nichols Institute Diagnostics
- Product
- Nichols Advantage ACTH Test System, catalog number 62-7004.
- Status
- Terminated
- Initiated
- 2005-04-22
- Posted
- 2005-07-28
- Terminated
- 2012-03-16
- Reason
- Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
- Root cause
- Other
- Action
- Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
- Quantity
- 1203
- Distribution
- Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden
- Lot, serial or model codes
- Lot 62-500040 and 62-404296
- 510(k) numbers
- ["K962601"]
- PMA numbers
- not on file
- Product code
- CKG
- 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