Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705
FDA device recall Z-0040-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Samples with high fat content will not count platelets accurately.
- Action taken
- Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 451
- Distribution
- United States and Canada
- Date initiated
- 2003-09-08
- Date posted
- 2003-10-15
- Date terminated
- 2004-03-30
- Location
- Brea, CA
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