Blood/EMB, Levine 100/PK, Product Number R02041
- Company
- Remel Inc
- Recall Initiated
- July 11, 2025
- Posted
- July 31, 2025
- Recall Number
- Z-2225-2025
- Quantity
- 750 units
- Firm Location
- Lenexa, KS
Reason for Recall
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 848838003684; Lot Numbers: 274194
Root Cause
Under Investigation by firm
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.