Recall Z-0902-2015 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
| Date | Jan 2, 2015 (initiated Nov 13, 2014) |
| Status | Terminated |
| Reason | HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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. The defect would result in a false high or false low results for HbA1c and false high results for magnes |
| Root cause | Package design/selection |
| Action | A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative. |
| Quantity | 443 units |
| Distribution | Nationwide in US |
| 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 |