Enforcement Report - Week of January 9, 2013
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0633-2013 |
| Classification | Class II |
| Code Info | Lot number: 00456-4108 |
| Product Distributed Qty | 384 units |
| 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. |
Event Detail
| Event Id | 63838 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Horiba Instruments, Inc dba Horiba Medical |
| City | Irvine |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX. |
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