Strep Selective II Agar, Product Number R01859
FDA Recall Z-2224-2025 · Posted 2025-07-31
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Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeJSI
Date Initiated2025-07-11
Product Quantity371 units
Reason for Recall
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Firm Action
An Urgent: Medical Device Recall notification letter dated 7/11/25 was sent to customers.
ACTIONS TO BE TAKEN BY THE CUSTOMER:
Our records indicate that you have received above products.
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 products listed above 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. Complete and return the response form even if you no longer have the affected product on hand. 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].
TYPE OF ACTION BY THE MANUFACTURER:
Remel Inc., part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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