remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for… recallZ-1201-2025 · Remel, Inc · initiated Feb 13, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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 [email protected]."
Recall details
- Recall number
- Z-1201-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 13, 2025
- Posted by the FDA
- Feb 20, 2025
- Recalling firm
- Remel, Inc
- Quantity
- 316 units
- Product code
- JSI
- Distribution
- US Nationwide distribution.
Product description
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Code information (models, lots, serial numbers)
UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REMEL R02041Remel, Inc. · Culture Media, Selective And Differential3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96312).
- Z-1200-2025 · Open, Classifiedremel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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