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Terminated

COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

FDA Recall Z-0805-03 · Posted 2003-05-09

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJQW
Date Initiated2003-03-28
Date Terminated2003-10-14
Product Quantity91

Reason for Recall

Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

Firm Action

The firm sent notification letter and modified operating instructions by mail on March 28, 2003.

Root Cause

Other

Distribution Pattern

USA and Canada

Official Source

View FDA Recall →

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

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