Automated Differential Cell Counter
FDA Recall Z-0002-05 · Posted 2004-10-05
Recalling FirmABX Diagnostics Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-08-13
Date Terminated2005-09-02
Product Quantity91
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.