FDA Medical Device Recalls (openFDA)
ABX Diagnostics Inc: ABX Pentra 120,120R,120DX, automated hematology analyzer
- Recall number
- Z-1334-06
- Recalling firm
- ABX Diagnostics Inc
- Product
- ABX Pentra 120,120R,120DX, automated hematology analyzer
- Status
- Terminated
- Initiated
- 2006-03-24
- Posted
- 2006-08-03
- Terminated
- 2012-05-23
- Reason
- Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
- Root cause
- Other
- Action
- Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- All serial numbers, all software versions.
- 510(k) numbers
- ["K022200","K050719"]
- 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