Recall Z-0494-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Horiba Instruments, Inc dba Horiba Medical
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
| Date | Nov 21, 2017 |
| Status | Terminated |
| Reason | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. |
| Root cause | Process control |
| Action | The firm initiated their recall by letter on 11/21/2017. The letter stated the following: "A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return |
| Quantity | 10 bags of 100 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) Horiba Abx, Dec 16, 2005 |