COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
This recall has been terminated (originally issued February 4, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- December 15, 2005
- Posted
- February 4, 2006
- Terminated
- January 26, 2012
- Recall Number
- Z-0475-06
- Quantity
- 1134
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
Distribution
Nationwide and Canada
Lot / Code Info
PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions
Root Cause
Other
Action Taken
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)
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