remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
- Company
- Remel Inc
- Recall Initiated
- February 13, 2025
- Posted
- February 20, 2025
- Recall Number
- Z-1201-2025
- Quantity
- 316 units
- Firm Location
- Lenexa, KS
Reason for Recall
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 848838003684, Lot Number 213971, exp. 2025-02-25
Root Cause
Under Investigation by firm
Action Taken
Thermo Fisher Scientific issued an Urgent Medical Device Recall notice to its consignees on 02/13/2025 via US Mail. The notice explained the problem with the product, potential risk to health, and requested the following: "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 R02049 and R02041 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. 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."