FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Cidexplus Solution Test Strips
- Recall number
- Z-0779-05
- Recalling firm
- Advanced Sterilization Products
- Product
- Cidexplus Solution Test Strips
- Status
- Terminated
- Initiated
- 2005-03-16
- Posted
- 2005-04-27
- Terminated
- 2007-03-20
- Reason
- CIDEX test strips were found to pass solution below MEC.
- Root cause
- Other
- Action
- Customers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
- Quantity
- 3422 cases (2 bottles per case)
- Distribution
- Nationwide & Puerto Rice
- Lot, serial or model codes
- Product Code: 2924 Lot Numbers: 011480, 011483, 011019 Product Code: 2926 Lot Numbers: 011283, 011020
- 510(k) numbers
- ["K981054"]
- PMA numbers
- not on file
- Product code
- JOJ
- Firm FEI
- 3003662624
- Firm city
- Irvine
- 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