Z-1127-03

Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G

Name: Z-1127-03 Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G
Creator: Meridian Bioscience Inc
Published: 2003-06-18
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2003-06-18 / Terminated

FDA source

Meridian Bioscience Inc began a recall of Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G on 2003-06-18. The reason FDA records is "The Low Positive Standard kit component is losing potency that may result in false positive test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1127-03
Status: Terminated
Initiated: 2003-06-18
Posted: 2003-08-12
Terminated: 2004-03-29
Recalling firm: Meridian Bioscience Inc
Product: Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: The Low Positive Standard kit component is losing potency that may result in false positive test results.
FDA root cause: Other
Action: The firm notified their customers by telephone and fax on 6/18/2003.
Quantity in commerce: 43 kits
Distribution: The kits were shipped to end-users located in CA, UT, NY, MD, KY; and to a foreign distributor in Belgium.
Product codes and lots: Lot Numbers: #03022371 and #03022472. All lots Exp Date: 2004-07.

Product code LFZ

K924096Class IICmv Elisa Test SystemZeus Scientific, Inc. / cleared 1993-04-02

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)