FDA Medical Device Recalls (openFDA)
Remel, Inc.: Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
- Recall number
- Z-0786-06
- Recalling firm
- Remel, Inc.
- Product
- Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
- Status
- Terminated
- Initiated
- 2006-02-14
- Posted
- 2006-04-22
- Terminated
- 2008-03-06
- Reason
- Some units exhibit weak false-positive reactions with some negative patient serum
- 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
- 27 units
- Distribution
- Nationwide-Distribution was made to a New Jersey distributor.
- Lot, serial or model codes
- Lot 382735, Exp. 2006/06/30
- 510(k) numbers
- ["K883540"]
- PMA numbers
- not on file
- Product code
- KTN
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28