FDA Medical Device Recalls (openFDA)
Nichols Institute Diagnostics: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
- Recall number
- Z-0810-05
- Recalling firm
- Nichols Institute Diagnostics
- Product
- Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
- Status
- Terminated
- Initiated
- 2005-04-07
- Posted
- 2005-05-10
- Terminated
- 2012-03-16
- Reason
- Values do not agree with Directional Instructions.
- Root cause
- Other
- Action
- Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.
- Quantity
- 13751
- Distribution
- Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden
- Lot, serial or model codes
- Lots 62-402598 and 62-402622
- 510(k) numbers
- ["K033727"]
- PMA numbers
- not on file
- Product code
- CEW
- 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