Z-0672-05

Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the...

Name: Z-0672-05 Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the...
Creator: Diasorin Inc.
Published: 2004-04-20
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-04-20 / Terminated

FDA source

Diasorin Inc. began a recall of Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay on 2004-04-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0672-05
Status: Terminated
Initiated: 2004-04-20
Posted: 2005-04-06
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
Product code: LLL Extractable Antinuclear Antibody, Antigen And Control
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 29
Distribution: CT, FL, NY, WA, TX, AR, TN, CANADA
Product codes and lots: software versions 9 thru 12

Product code LLL

K944505Class IIDiastat Ena Single Well Screen KitShield Diagnostics, Ltd. / cleared 1994-11-21

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)