Recall Z-0633-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Horiba Instruments, Inc dba Horiba Medical
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.
| 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 | 384 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
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS, Nov 8, 2011 |