Strep Selective II Agar, Product Number R01859

FDA device recall Z-2224-2025 · posted 2025-07-31 · Open, Classified

Recall details

Recalling firm

Remel, Inc

Reason for recall

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Action taken

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 MBD.vigilance@thermofisher.com 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 microbiology.ts.us@thermofisher.com. 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

Status

Open, Classified

Product code

JSI

Quantity affected

371 units

Distribution

US Nationwide distribution.

Date initiated

2025-07-11

Date posted

2025-07-31

Location

Lenexa, KS

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