Z-0786-06

Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd...

Name: Z-0786-06 Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd...
Creator: Remel, Inc.
Published: 2006-02-14
License: https://open.fda.gov/license/

Remel Inc / initiated 2006-02-14 / Terminated

FDA source

Remel, Inc. began a recall of Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England on 2006-02-14. The reason FDA records is "Some units exhibit weak false-positive reactions with some negative patient serum". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0786-06
Status: Terminated
Initiated: 2006-02-14
Posted: 2006-04-22
Terminated: 2008-03-06
Recalling firm: Remel Inc
Product: Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
Product code: KTN System, Test, Infectious Mononucleosis
Reason for recall: Some units exhibit weak false-positive reactions with some negative patient serum
FDA root cause: Other
Action: The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed. The distributor was audited by FDA to assure subrecall
Quantity in commerce: 27 units
Distribution: Nationwide-Distribution was made to a New Jersey distributor.
Product codes and lots: Lot 382735, Exp. 2006/06/30

Product code KTN

K883540Class IIOxoid Infectious Mononucleosis KitUnipath , Ltd. / cleared 1988-10-19

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)