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.
FDA Recall Z-0674-05 · Posted 2005-04-06
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMSV
Date Initiated2004-10-26
Date Terminated2006-07-22
Product Quantity7
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.
Firm Action
Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
Root Cause
Other
Distribution Pattern
CT, MI, MT, UT & CANADA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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