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.
- 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)
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:
- laboratories utilizing same-slide controls as routine practice.
- assays in which a biologic internal control is always present (e.g. HER2 Dual ISH).
- individual cases containing internal biologic controls.
- 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.
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.
|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|