🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2022 Ventana Medical Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ventana Medical Systems, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0907-2023

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