Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
This recall has been terminated (originally issued April 6, 2005).
- Company
- Diasorin Inc.
- Recall Initiated
- April 20, 2004
- Posted
- April 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0672-05
- Quantity
- 29
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
Reason for Recall
An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
Distribution
CT, FL, NY, WA, TX, AR, TN, CANADA
Lot / Code Info
software versions 9 thru 12
Root Cause
Other
Action Taken
Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
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