Recall Z-0904-2014 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
| Date | Jan 31, 2014 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. |
| Root cause | Under Investigation by firm |
| Action | Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instruct |
| Quantity | 698 units total (80 units in US) |
| Distribution | Worldwide Distribution - USA (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 |