Recall Z-2225-2025 ยท JSI Culture Media, Selective And Differential
Remel, Inc
Blood/EMB, Levine 100/PK, Product Number R02041
| Date | Jul 31, 2025 (initiated Jul 11, 2025) |
| Status | Open, Classified |
| Reason | The products may contain surface and subsurface contamination of Listeria monocytogenes. |
| Root cause | Under Investigation by 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 MBD.vigilance@thermofisher.com in order f |
| Quantity | 750 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.