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Terminated

ABX Diagnostices Pentra 60C+ Hematology Analyzer

FDA Recall Z-1149-03 · Posted 2003-08-21

Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2003-06-04
Date Terminated2014-06-17
Product Quantity159

Reason for Recall

Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.

Firm Action

The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003677ABX PENTRA 60C+ HEMATOLOGY ANALYZERAbx Diagnostics · 2000-12-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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