FDA Medical Device Recalls (openFDA)
ABX Diagnostics Inc: ABX Diagnostices Pentra 60C+ Hematology Analyzer
- Recall number
- Z-1149-03
- Recalling firm
- ABX Diagnostics Inc
- Product
- ABX Diagnostices Pentra 60C+ Hematology Analyzer
- Status
- Terminated
- Initiated
- 2003-06-04
- Posted
- 2003-08-21
- Terminated
- 2014-06-17
- Reason
- Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
- Root cause
- Other
- Action
- The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.
- Quantity
- 159
- Distribution
- Nationwide.
- Lot, serial or model codes
- Software versions of up to 1.7
- 510(k) numbers
- ["K003677"]
- 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