FDA Device recall Z-0633-2013
PENTRA C200, Part Number: A11A01629
- FDA Device
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of PENTRA C200, Part Number: A11A01629 by Horiba Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0633-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-10 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Horiba Instruments |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Lot number: 00456-4108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Horiba Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0633-2013%22
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