FDA Medical Device Recalls (openFDA)
Diagnostic Products Corp: Immulite 2500 insulin Kit
- Recall number
- Z-0324-05
- Recalling firm
- Diagnostic Products Corp
- Product
- Immulite 2500 insulin Kit
- Status
- Terminated
- Initiated
- 2004-11-19
- Posted
- 2004-12-17
- Terminated
- 2005-03-24
- Reason
- Low bias of 10 to 40% at different levels of insulin in samples.
- Root cause
- Other
- Action
- Customers were notified by telephone on 11/19/2004. They were instructed to discard remaining kits.
- Quantity
- 10 kits
- Distribution
- Medical facilities in AK, NY, WI.
- Lot, serial or model codes
- lot 102A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CFP
- Firm FEI
- 3005250747
- Firm city
- Los Angeles
- 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