—#44188

Product

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

FDA product code: KTN — System, Test, Infectious Mononucleosis
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K883540
Affected lot / code info: Lot 382735, Exp. 2006/06/30

Why it was recalled

Some units exhibit weak false-positive reactions with some negative patient serum

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Remel, Inc.
Address: 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Nationwide-Distribution was made to a New Jersey distributor.

Timeline

Recall initiated: 2006-02-14
Posted by FDA: 2006-04-22
Terminated: 2008-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44188. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.