Recall Z-1141-2013
Horiba Instruments, Inc dba Horiba Medical · initiated March 20, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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."
Details
- Recall number
- Z-1141-2013
- Initiated
- March 20, 2013
- Posted by FDA
- April 18, 2013
- Terminated
- September 26, 2014
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Quantity
- 905 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical, Irvine, CA