Atlas FDA

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

FDA device recall Z-0570-03 · posted 2003-02-25 · Terminated

Recall details

Recalling firm
Beckman Coulter Inc
Reason for recall
Failure to cycle properly ammong samples.
Action taken
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
Status
Terminated
Quantity affected
351
Distribution
US and Canada
Date initiated
2003-01-20
Date posted
2003-02-25
Date terminated
2003-07-26
Location
Brea, CA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
ABX PENTRA 60C+ HEMATOLOGY ANALYZER (K003677)Abx Diagnostics2000-12-26