Z-1141-2013 Class II Terminated
FDA device recall Z-1141-2013 was initiated by Horiba Instruments, Inc dba Horiba Medical on March 20, 2013 and is designated Class II. 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 Analyze… The recall status is terminated (terminated September 26, 2014). Affected quantity: 905 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 20, 2013
- Termination Date
- September 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 905 units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below