Recall Z-0632-2013 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Horiba Instruments, Inc dba Horiba Medical
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.
| Date | Jan 3, 2013 (initiated Oct 10, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Horiba Medical sent a Field Safety Notification and Acknowledgement Letter dated November 20, 2012, to all affected customers. The letter notified the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 calendar days via mail, email or fax. Customers with questions were instructed to contact their local representative. For questions regarding this recall call 714-273-9254. |
| Quantity | 66886 units |
| Distribution | Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, Aug 8, 2006 |