ABX Pentra 120,120R,120DX, automated hematology analyzer
This recall has been terminated (originally issued August 3, 2006).
- Company
- Abx Diagnostics Inc
- Recall Initiated
- March 24, 2006
- Posted
- August 3, 2006
- Terminated
- May 23, 2012
- Recall Number
- Z-1334-06
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
Distribution
Nationwide
Lot / Code Info
All serial numbers, all software versions.
Root Cause
Other
Action Taken
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.