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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Ventana Medical Systems Inc: Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.

Agency Publication Date: February 27, 2018
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Affected Products

Product: OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

UDI 04015630984039, Lot Numbers: Y19271, Y11625, Y24225, Y15571

Lot Numbers:
Numbers
Product: ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic

UDI 04015630984039, Lot Numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147

Lot Numbers:
Numbers
Product: iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic

UDI 04015630971749, Lot Numbers: Y11834, Y24245

Lot Numbers:
Numbers
Product: ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

UDI 04015630972296, Lot Number: Y15133

Lot Numbers:
Number
Product: ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

UDI 04015630970384, Lot Number: Y15146

Lot Numbers:
Number
Product: CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic

UDI 04015630972807, Lot Numbers: Y14122, Y18107

Lot Numbers:
Numbers
Product: CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

UDI 04015630976287, Lot Numbers: Y22162, Y15546

Lot Numbers:
Numbers
Product: OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447

Lot Numbers:
Numbers
Product: OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

UDI 04015630984749, Lot Numbers: Y19318

Lot Numbers:
Numbers
Product: Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

Lot Numbers:
Numbers
Product: ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

UDI 04015630972135, Lot Number: Y17990

Lot Numbers:
Number
Product: NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

UDI 04015630970254, Lot Number: Y15392

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78942
Status: Resolved
Manufacturer: Ventana Medical Systems Inc
Manufactured In: United States
Units Affected: 12 products (12028 units; 72730 units; 1980 units; 6 units; 20 units; 748 units; 18 units; 5040 units; 518 units; 71640 units; 358 units; 3122 units)
Agency Last Updated: September 14, 2018

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.