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Terminated

Automated Differential Cell Counter

FDA Recall Z-0003-05 · Posted 2004-10-05

Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-08-13
Date Terminated2005-09-02
Product Quantity3

Reason for Recall

Device can generate overestimated platelet results.

Firm Action

Software problem, device may give overestimated platelet results.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024002PENTRA 80Abx Diagnostics · 2003-01-03

Official Source

View FDA Recall →

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

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