ABX Pentra 120,120R,120DX, automated hematology analyzer
FDA device recall Z-1334-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- ABX Diagnostics Inc
- Reason for recall
- Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Distribution
- Nationwide
- Date initiated
- 2006-03-24
- Date posted
- 2006-08-03
- Date terminated
- 2012-05-23
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABX PENTRA DX 120: OPTION SPS EVOLUTION (K050719) | Horiba Abx | 2005-04-26 |
| PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (K022200) | Abx Diagnostics | 2002-07-29 |