Medical Devices

Ventana Medical Systems Recalls Multiple Detection Kits Due to Potential for False Negative Results Caused by Reagent Dispenser Issues

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Name: Detection kits using the FLO-LOK III Dispenser
  • Serial Numbers: Full List of Affected Products
  • Manufacturing Dates: May 16, 2017 to December 12, 2017
  • Distribution Dates: July 24, 2017 to March 29, 2018
  • Devices recalled in the U.S: 38,000 kits (number of dispensers varies per kit)

Device Use

The detection kits contain staining chemicals (reagents) used during immunohistochemistry (IHC) lab tests. The dispensers release the staining reagents that change color to indicate a disease state or health condition (biomarkers). Biomarkers are used as an aid in the diagnosis and management of patient treatment for many health conditions, including cancer. The results can also indicate whether a patient is likely to benefit from certain drugs.

Reason for Recall

Ventana Medical Systems is recalling the detection kits due to leaking and sticking of reagent dispensers which could cause a test result to indicate the absence of a biomarker when, in fact, the person does express the biomarker (false negative). A false negative may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences. There are no deaths or serious health problems that have been reported.

Who May be Affected

  • Health care providers who use detection kits to identify biomarkers as an aid in disease diagnosis and management of patient treatment.
  • Certain cancer patients who undergo biomarker testing as an aid in diagnosis and management.

What to Do - Health Care Providers

On August 2, 2018, Ventana Medical Systems sent Field Safety Notices to all affected customers and asked them to:

  • Discontinue the use of all affected dispensers for clinical testing from “Previously Communicated Lots
  • Perform a retrospective review and re-testing (if applicable) of clinical cases involving an affected dispenser lot that did not include a same-slide control. The ultimate scope of the re-testing is at the medical discretion of each laboratory in accordance with local hospital/laboratory procedures and policies, but should include at a minimum those assays used as the sole determinant for patient therapy or decision-making (e.g. HER2, ER/PR, ALK, PD-L1 (SP142), PD-L1(SP263) and C-Kit(9.7)).

Review/re-testing is typically not necessary for:

  1. laboratories utilizing same-slide controls as routine practice.
  2. assays in which a biologic internal control is always present (e.g. HER2 Dual ISH).
  3. individual cases containing internal biologic controls.
  4. individual cases that were already re-tested in association with the original RTD field notification and re-testing recommendation (FSN-RTD-2017-001).

Contact Ventana Medical Systems for further instructions relating to temporary replacement possibilities.

Contact Information

Customers with questions may contact Ventana Medical Systems at 1-800-227-2155 ext 7035.

Date Recall Initiated

August 2, 2018

How Do I Report a Problem?

Health care providers and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Full List of Affected Products

Product Name GMMI Number Expanded Affected Lots Previously Communicated Lots
OptiView DAB IHC Detection Kit 06396500001 Y24225, Y25760, E00119 Y19271, Y11625, Y15571
ULTRAVIEW UNIVERSAL DAB DETECTION KIT 05269806001 Y22147, Y25695 Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069
iView DAB Detection Kit 05266157001 Y24245 Y11834
ultraView SISH Detection Kit 05271967001 None Y15133
ultraView SISH DNP Detection Kit US 05572037001 Y24347 Y15146
CINtec PLUS Cytology Kit (CE-IVD) 06889565001 None Y14122, Y18107
OptiView Amplification Kit 06396518001 None Y15435, Y19322, Y22447
OptiView Amplification Kit (250 Test) 06718663001 Y26282 Y19318
ultraView SISH DNP Detection Kit 05907136001 Y26299 Y17990
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT 05266084001 Y22285, Y25750 Y15392
CINtec PLUS Cytology Kit (Canada Class 2, Japan RUO) 06889549001 None Y22162, Y15546
Hematoxylin II 05277965001 None Y10759, Y13938, Y17402, Y17403, Y21312
iView DAB Detection Kit w/o Secondary Antibody 05266173001 Y19981  
ISH iVIEW Blue Plus Detection Kit 05266181001 Y15410, Y24365  
ANTI-PAN KERATIN Primary Antibody, 25mL 05266840001 Y21610  
ultraView Universal Alkaline Phosphatase Red Detection Kit 05269814001 Y15071, Y18053, Y22469  
ISH Protease 3 05273331001 Y13927, Y18872, Y22569, Y25883  
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody 05278392001 Y12992, Y18852, Y23051  
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody 05278414001 Y18586, Y24472  
VENTANA ISH iView Blue Detection Kit 05278511001 Y15105, Y22455  
INFORM HPV III Family 16 Probe (B) 05278856001 Y19417  
VENTANA Basal Cell Cktl (34βE12+p63)250 06419445001 Y20881  
VENTANA anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody 06425623001 Y12986, Y16448, Y24119, Y16912Z  
CINtec HISTOLOGY (250) 06680011001 Y23135  
CINtec p16 Histology (250) 06695230001 Y13547, Y19158  
CINtec p16 Histology (250) CE 06695256001 Y16507, Y23040  

Page Last Updated: 09/28/2018
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