FDA Medical Device Recalls (openFDA)
Remel, Inc: remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
- Recall number
- Z-1200-2025
- Recalling firm
- Remel, Inc
- Product
- remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
- Status
- Open, Classified
- Initiated
- 2025-02-13
- Posted
- 2025-02-20
- Terminated
- not on file
- Reason
- Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
- Root cause
- Under Investigation by firm
- Action
- Thermo Fisher Scientific issued an Urgent Medical Device Recall notice to its consignees on 02/13/2025 via US Mail. The notice explained the problem with the product, potential risk to health, and requested the following: "Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of the potential for visible contamination of R02049 and R02041 and destroy any remaining inventory of lots listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to MBD.vigilance@thermofisher.com in order for your replacement/credit to be processed. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com."
- Quantity
- 787 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 848838003691, Lot Number 213926, exp. 2025-02-24
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSI
- 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