Access Immunoassay Systems Assay Protocol: Dil-AFP.
This recall has been terminated (originally issued August 23, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 18, 2005
- Posted
- August 23, 2005
- Terminated
- March 7, 2012
- Recall Number
- Z-1388-05
- Quantity
- 311 USA 16 Canada
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.
Distribution
Nationwide and Canada
Lot / Code Info
All lot numbers.
Root Cause
Other
Action Taken
Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions.
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