Z-2201-2011

Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software...

Name: Z-2201-2011 Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software...
Creator: Bio-Rad Laboratories
Published: 2010-07-19
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-07-19 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories began a recall of Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files... on 2010-07-19. The reason FDA records is "The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2201-2011
Status: Terminated
Initiated: 2010-07-19
Posted: 2011-05-19
Terminated: 2011-08-25
Recalling firm: Bio-Rad Laboratories Inc.
Product: Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall: The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
Root cause tag: software
FDA root cause: Software design
Action: Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.
Quantity in commerce: 272
Distribution: Nationwide Distribution -- Including Puerto Rico.
Product codes and lots: APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2

Product code LFX

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)