Z-0632-2013 Class II Terminated
FDA device recall Z-0632-2013 was initiated by Horiba Instruments, Inc dba Horiba Medical on October 10, 2012 and is designated Class II. Reason for recall: Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AS… The recall status is terminated (terminated September 12, 2013). Affected quantity: 66886 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2013
- Initiation Date
- October 10, 2012
- Termination Date
- September 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66886 units
Product Description
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
Reason for Recall
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.
Distribution Pattern
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Code Information
Lot number: 00456-4108