ABX Diagnostics Inc Recalls
Showing 1-5 of 5 recalls
ABX Diagnostices Pentra 60C+ Hematology Analyzer
Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
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.
ABX Pentra 120,120R,120DX, automated hematology analyzer
Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
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.
Pentra 80 and Pentra 80XL Hematology Analyzers
Software defect, instrument may erroneously give a result of '0' or '---'.
Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
Power failure having impact on software.
Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
Automated Differential Cell Counter
Device can generate overestimated platelet results.
Software problem, device may give overestimated platelet results.