FDAFDA · Food and drugs·Recall number Z-1141-2013
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.
Published April 24, 2013 · Recall initiated: March 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- Nationwide Distribution.
- Lot
- Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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