FDA Medical Device Recalls (openFDA)
ABX Diagnostics Inc: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
- Recall number
- Z-1342-04
- Recalling firm
- ABX Diagnostics Inc
- Product
- PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
- Status
- Terminated
- Initiated
- 2004-06-24
- Posted
- 2004-08-13
- Terminated
- 2005-09-02
- Reason
- Power failure having impact on software.
- Root cause
- Other
- Action
- Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
- Quantity
- 81
- Distribution
- Nationwide.
- Lot, serial or model codes
- Any instrument which is not equipped with v4.55 or above will be upgraded.
- 510(k) numbers
- ["K022200"]
- PMA numbers
- not on file
- Product code
- GJH
- 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