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Terminated

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

FDA Recall Z-0786-06 · Posted 2006-04-22

Recalling FirmRemel, Inc.
Recall StatusTerminated
Product CodeKTN
Date Initiated2006-02-14
Date Terminated2008-03-06
Product Quantity27 units

Reason for Recall

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

Firm 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

Root Cause

Other

Distribution Pattern

Nationwide-Distribution was made to a New Jersey distributor.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K883540OXOID INFECTIOUS MONONUCLEOSIS KITUnipath , Ltd. · 1988-10-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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