Recall Z-1334-06 ยท GKZ Counter, Differential Cell
ABX Diagnostics Inc
ABX Pentra 120,120R,120DX, automated hematology analyzer
| Date | Aug 3, 2006 (initiated Mar 24, 2006) |
| Status | Terminated |
| 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. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |