Recall Z-2692-2014 ยท JGJ Photometric Method, Magnesium
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of
| Date | Sep 24, 2014 (initiated Aug 11, 2014) |
| Status | Terminated |
| Reason | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim. |
| Root cause | Other |
| Action | Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266. |
| Quantity | 359 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, Jul 21, 2006 |