FDA Medical Device Recalls (openFDA)
Nichols Institute Diagnostics: Nichols IRMA Intact PTH Assay, catalog No. 40-2171
- Recall number
- Z-0809-05
- Recalling firm
- Nichols Institute Diagnostics
- Product
- Nichols IRMA Intact PTH Assay, catalog No. 40-2171
- Status
- Terminated
- Initiated
- 2005-03-25
- Posted
- 2005-05-10
- Terminated
- 2012-03-16
- Reason
- Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
- Root cause
- Other
- Action
- Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.
- Quantity
- Not divulged
- Distribution
- Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
- Lot, serial or model codes
- Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005
- 510(k) numbers
- ["K861797"]
- 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