Atlas FDA

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

FDA device recall Z-0805-03 · posted 2003-05-09 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
Action taken
The firm sent notification letter and modified operating instructions by mail on March 28, 2003.
Root cause
Other
Status
Terminated
Product code
JQW
Quantity affected
91
Distribution
USA and Canada
Date initiated
2003-03-28
Date posted
2003-05-09
Date terminated
2003-10-14
Location
Brea, CA

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