FDA Medical Device Recalls (openFDA)
International Remote Imaging Systems Inc: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
- Recall number
- Z-0884-05
- Recalling firm
- International Remote Imaging Systems Inc
- Product
- IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
- Status
- Terminated
- Initiated
- 2005-04-29
- Posted
- 2005-06-11
- Terminated
- 2012-05-07
- Reason
- Nonconformance to performance specifications.
- Root cause
- Other
- Action
- Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.
- Quantity
- 107
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot No. 103-05
- 510(k) numbers
- ["K945913"]
- PMA numbers
- not on file
- Product code
- JJW
- Firm FEI
- 2023446
- Firm city
- Chatsworth
- 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