Blood/MacConkey Biplate 100/PK, Product Number R02049
Recall
- Recall Number
- Z-2226-2025
- Event Number
- 97224
- Firm
- Remel, Inc
- FEI Number
- 1924669
- Product Code
- JSI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 11, 2025
- Posted
- July 31, 2025
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
Blood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
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.
US Nationwide distribution.
611 untis