ABX Diagnostics Inc ABX Pentra 120,120R,120DX, automated hematology analyzer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABX Pentra 120,120R,120DX, automated hematology analyzer
Brand
ABX Diagnostics Inc
Lot Codes / Batch Numbers
All serial numbers, all software versions.
Products Sold
All serial numbers, all software versions.
ABX Diagnostics Inc is recalling ABX Pentra 120,120R,120DX, automated hematology analyzer due to Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026