FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Recall number
- Z-1019-2026
- Recalling firm
- Meridian Bioscience Inc
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Status
- Open, Classified
- Initiated
- 2025-12-05
- Posted
- 2026-01-05
- Terminated
- not on file
- Reason
- The affected lots show a decline in performance over time, which may lead to false-negative results.
- Root cause
- Under Investigation by firm
- Action
- An "URGENT MEDICAL DEVICE CORRECTION" dated 12/1/25 was sent to customers. Required Actions: " Identify and segregate any remaining inventory of impacted product lots and suspend further use. " Destroy remaining inventory of impacted product lot in accordance with state, local, and/or federal regulations. o Contact Technical Service for replacement product. " Review previously obtained results from Revogene C. difficile listed Lots numbers. Any negative results obtained should be re-evaluated in conjunction with presented clinical findings to determine if retesting is required. " Complete and return the CONFIRMATION OF NOTIFICATION Form. Complete this form even if there is no remaining inventory. Actions to Be Taken By Meridian Bioscience, Inc.: Meridian Bioscience, Inc. will replace any unused inventory and provide support for any necessary retesting, including replacement test materials as needed. Contact Information: For any question regarding this notification please call Meridian Bioscience Technical Service at 1-800-343-3858, or email at FieldActionSupport@meridianbioscience.com.
- Quantity
- 211 units
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Lot, serial or model codes
- UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
- 510(k) numbers
- ["K172569"]
- PMA numbers
- not on file
- Product code
- OZN
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- 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