Recall Z-0289-2013 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is
| Date | Nov 14, 2012 (initiated Sep 14, 2012) |
| Status | Terminated |
| Reason | This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay. |
| Root cause | Nonconforming Material/Component |
| Action | HORIBA Medical sent customer communication letters dated October 24, 2011, to all affected customers via Fax with the exception of two communications that were emailed. The response or confirmation of receipt was conducted via telephone and also documented on attached Notification List. Customers were given a list of procedures to follow and asked to complete and fax the Acknowledgement of Receipt Form to +33 (0)4 67 14 15 17. For questions regarding this recall call 949-453-0500, ext 208. |
| Quantity | 8,503 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H Horiba Abx, Nov 30, 2007 |