Z-1201-2025Class II

remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

Name: Z-1201-2025 remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Creator: Remel, Inc
Published: 2025-02-13
License: https://open.fda.gov/license/

Remel Inc / initiated 2025-02-13 / Open, Classified / root cause: packaging

FDA source

Remel, Inc began a recall of remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use on 2025-02-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1201-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-13
Posted: 2025-02-20
Recalling firm: Remel Inc
Product: remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Product code: JSI Culture Media, Selective And Differential
Reason for recall: 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 tag: packaging
FDA 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 [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]."
Quantity in commerce: 316 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1201-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1200-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20
Z-1201-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-20

Product code JSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)