FDA Medical Device Recalls (openFDA)
ABX Diagnostics Inc: Automated Differential Cell Counter
- Recall number
- Z-0002-05
- Recalling firm
- ABX Diagnostics Inc
- Product
- Automated Differential Cell Counter
- Status
- Terminated
- Initiated
- 2004-08-13
- Posted
- 2004-10-05
- Terminated
- 2005-09-02
- Reason
- Device can generate overestimated platelet results.
- Root cause
- Other
- Action
- Software problem, device may give overestimated platelet results.
- Quantity
- 91
- Distribution
- Nationwide
- Lot, serial or model codes
- Part Numbers: Pentra 80 P8000000NUA10
- 510(k) numbers
- ["K024002"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3002698356
- 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