The Recall Desk

FDA (Devices) recall action 69276

Richard-Allan Scientific Company recalled 7 products on 2014-10-15

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2014-10-15
Critical
0
Units
1,621

Why these products were recalled

The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 264 cases of its Specimen Transportation System because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls Specimen Transportation System Due to Concentration Issues

    Richard-Allan Scientific is recalling 285 cases of its Specimen Transportation System because the NBF concentrations may not meet specifications.

    Product
    Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls Bio-Tite Specimen Containers Due to Concentration Issues

    Richard-Allan Scientific is recalling Bio-Tite Specimen Containers because the NBF concentration may be outside specifications.

    Product
    Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

    Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

    Product
    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states
  • SevereFDA (Devices)··2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Distribution
    34 states