Remel, Inc. Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
Brand
Remel, Inc.
Lot Codes / Batch Numbers
Lot 382735, Exp. 2006/06/30
Products Sold
Lot 382735, Exp. 2006/06/30
Remel, Inc. is recalling Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., B due to Some units exhibit weak false-positive reactions with some negative patient serum. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some units exhibit weak false-positive reactions with some negative patient serum
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026