BEUDAMED
    FDA Enforcement Class II Terminated

    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.

    Recall: Z-2351-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2351-2016
    Event ID
    74557
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 13, 2016
    Classification Date
    August 5, 2016
    Termination Date
    November 8, 2016
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590, United States

    Description

    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.

    Reason

    potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.

    Code Info

    Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020

    Distribution

    Distributed in the states of FL, PA, NY, MD, CA, and AZ.

    Quantity

    18 cases