Z-0907-2023 Class II Ongoing

Recalled by Ventana Medical Systems, Inc. — Oro Valley, AZ

Recall Details

Product Type
Devices
Report Date
January 18, 2023
Initiation Date
November 18, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,927 kits

Product Description

VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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