The Recall Desk

FDA (Devices) recall action 67897

Alfa Wassermann, Inc. recalled 2 products on 2014-05-07

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-05-07
Critical
0
Units
731

Why these products were recalled

Extremely low absorbance readings.

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.

1–2 of 2

  • ModerateFDA (Devices)··2014-05-07

    Alfa Wassermann ACE AST Reagent Recalled for Low Absorbance Readings

    Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.

    Product
    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-05-07

    Alfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings

    Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.

    Product
    Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories
    Category
    Distribution
    0 states