Z-0674-05

Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader)...

Name: Z-0674-05 Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader)...
Creator: Diasorin Inc.
Published: 2004-10-26
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-10-26 / Terminated

FDA source

Diasorin Inc. began a recall of Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA... on 2004-10-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0674-05
Status: Terminated
Initiated: 2004-10-26
Posted: 2005-04-06
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: 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.
Product code: MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
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.
FDA root cause: Other
Action: Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
Quantity in commerce: 7
Distribution: CT, MI, MT, UT & CANADA
Product codes and lots: software version 12

Product code MSV

K982879Class IIShield Diastat Anti-B2 Glycoprotein 1 Igg (Elisa) AssayShield Diagnostics, Ltd. / cleared 1998-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)