Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.
- Company
- Diasorin Inc.
- Recall Initiated
- October 26, 2004
- Posted
- April 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0674-05
- Quantity
- 7
- Firm Location
- Stillwater, MN
Reason for Recall
Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
Distribution
CT, MI, MT, UT & CANADA
Lot / Code Info
software version 12
Root Cause
Other
Action Taken
Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
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