Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
This recall has been terminated (originally issued April 6, 2005).
- Company
- Diasorin Inc.
- Recall Initiated
- April 12, 2004
- Posted
- April 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0673-05
- Quantity
- 8
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
Distribution
CA, CT, KS, MA & WA
Lot / Code Info
Software version 12
Root Cause
Other
Action Taken
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
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