Recall Z-2644-2024 ยท NJT Immunohistochemistry Reagents And Kits
Ventana Medical Systems, Inc.
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
| Date | Aug 16, 2024 (initiated Jun 27, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. |
| Root cause | Unknown/Undetermined by firm |
| Action | On July 5, 2024, Ventana Medical Systems, Inc. a subsidiary of Roche Diagnostics issued a "Urgent Medical Device Correction" via UPS to affected consignees. Ventana asked consignees to take the following actions: 1. Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. 2. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. 3. Review all positive results generated with the affected lots. Follow your standard laboratory operating procedures to investig |
| Quantity | 22,839 kits |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Austria, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.