Beckman Coulter Inc COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
PN 6605632, 6605632R, GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions
Products Sold
PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions
Beckman Coulter Inc is recalling COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 66 due to There is a risk of sample misidentification when processing samples in the Manual aspiration mode.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
Recommended Action
Per FDA guidance
A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026