Ventana Pd-l1 recall
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA…
Why was Ventana Pd-l1 recalled?
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI Code: 04015630967155 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 F30596 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G27114 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G31438 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H03958 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H13049 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H35110 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J12769 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J18775 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J25361 UDI-DI Code: 07613336106709 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 F31427 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G06715 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G16831 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G24564 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H00001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H07164 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H15132 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H18578 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H23050 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J00572 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J01568 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J14244 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J20989 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H08373 UDI-DI Code: 04015630976591 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H17865 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H30521 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H35111 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J11932 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J20132
- Product
- VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA…
- Recalling firm
- Ventana Medical Systems, Inc.
- Quantity
- 8,927 kits
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom, Albania, Armenia, Bangladesh, Belarus, Costa Rica, Cote d'Ivoire, Cuba, Dominican Republic, Egypt, El Salvador, Ghana, Guatemala, Iran, Israel, Jordan, Kenya, Kosovo, Kuwait, Lebanon, Mauritius, Morocco, Myanmar, Nigeria, North Macedonia, Oman, Panama, Philippines, Russian Fed., Saudi Arabia, Serbia, South Africa, Tanzania, Turkey, Turkmenistan and United Arab Emirates. Update (04-Jan-2023): Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Honduras, Indonesia, India, Japan, Korea, Mexico, Malaysia, New Zealand, Peru, Pakistan, Paraguay, Singapore, Thailand, Taiwan, Uruguay and Vietnam.
- Recall date
- January 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)