Recall Z-1141-2013 ยท JGS Electrode, Ion Specific, Sodium
Horiba Instruments, Inc dba Horiba Medical
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
| Date | Apr 18, 2013 (initiated Mar 20, 2013) |
| Status | Terminated |
| Reason | HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay. |
| Root cause | Software design |
| Action | A recall letter, Field Safety Notice & Acknowledgement mailed to the customers March 20, 2013. The letter included the product information, reason for recall, instructions on what to do with the recalled product, and contact information:"If you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory. Please contact your Customer Service Representative at 1-888-903-5001 (option 3) for any additional questions related to this customer letter." |
| Quantity | 905 units |
| Distribution | Nationwide Distribution. |
| 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 |