Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
FDA Recall Z-0673-05 · Posted 2005-04-06
Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeDBM
Date Initiated2004-04-12
Date Terminated2006-07-22
Product Quantity8
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
CA, CT, KS, MA & WA
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.