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Terminated

AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter

FDA Recall Z-0570-03 · Posted 2003-02-25

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Date Initiated2003-01-20
Date Terminated2003-07-26
Product Quantity351

Reason for Recall

Failure to cycle properly ammong samples.

Firm Action

Customers were sent a letter dated January 20, 2003 that describes this situation and provides modified operating instructions to prevent the occurence.

Root Cause

Other

Distribution Pattern

US and Canada

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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