FDA Medical Device Recalls (openFDA)
ABX Diagnostics Inc: Pentra 80 and Pentra 80XL Hematology Analyzers
- Recall number
- Z-0298-06
- Recalling firm
- ABX Diagnostics Inc
- Product
- Pentra 80 and Pentra 80XL Hematology Analyzers
- Status
- Terminated
- Initiated
- 2004-04-08
- Posted
- 2005-12-23
- Terminated
- 2006-02-06
- Reason
- Software defect, instrument may erroneously give a result of '0' or '---'.
- Root cause
- Other
- Action
- Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
- Quantity
- 67
- Distribution
- Nationwide.
- Lot, serial or model codes
- All Serial numbers.
- 510(k) numbers
- not on file
- 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