Z-1045-2009

RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno...

Name: Z-1045-2009 RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno...
Creator: Immuno Concepts Inc
Published: 2008-11-25
License: https://open.fda.gov/license/

IMMUNO CONCEPTS, NA, Ltd. / initiated 2008-11-25 / Terminated / root cause: manufacturing process

FDA source

Immuno Concepts Inc began a recall of RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA on 2008-11-25. The reason FDA records is "In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1045-2009
Status: Terminated
Initiated: 2008-11-25
Posted: 2009-04-06
Terminated: 2009-11-17
Recalling firm: IMMUNO CONCEPTS, NA, Ltd.
Product: RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Product code: LLL Extractable Antinuclear Antibody, Antigen And Control
Reason for recall: In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm has issued telephone calls, e-mails and notification letters to its consignees.
Quantity in commerce: 25 kits
Distribution: Worldwide Distribution including USA, Australia, England, Sweden and Austria.
Product codes and lots: Kit Catalog Number 7096-09, Lot Number 0821407 and Kit Catalog Number 7696-09, Lot Number 0821404.

Product code LLL

K935129Class IIRelisa Ena Antibody Screening Test SystemImmuno Concepts, Inc. / cleared 1994-01-31

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)