Z-2644-2024Class II

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

Name: Z-2644-2024 Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Creator: Ventana Medical Systems, Inc.
Published: 2024-06-27
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2024-06-27 / Open, Classified

FDA source

Ventana Medical Systems, Inc. began a recall of Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD on 2024-06-27. FDA classified it as Class II and gives the reason as "Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2644-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-27
Posted: 2024-08-16
Recalling firm: Ventana Medical Systems Inc
Product: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
FDA 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 investigate any suspected false positive results generated with the affected lots. 4. If you performed your initial validation using an affected lot, you should revalidate. 5. Refer to the Product Replacement or Credit section on page three of this UMDC. To receive replacement product OR credit for the unexpired product currently in your inventory, use the following link to access the form: https://go.roche.com/TP-02194. 6. Complete all sections of the enclosed Recall Response form (TP-02195); fax or email it according to the instructions on the form even if you are not requesting replacement product or credit. " Share this notification with all device users within your facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred. " File this Urgent Medical Device Correction (UMDC) for future reference.
Quantity in commerce: 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, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Albania, Argentina, Armenia, Australia, Azerbaijan, Bahrain, Belarus, Brazil, Cameroon, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Georgia, Ghana, Guatemala, Honduras, Hong Kong, India, Iran, Iraq, Israel, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mali, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nicaragua, Nigeria, North Macedonia, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Tanzania, Thailand, T¿rkiye, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: UDI: 04015630972579/J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, and M00669

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2644-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2644-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-16

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)