The Recall Desk

Manufacturer

Alfa Wassermann, Inc.

3 recalls in our database name Alfa Wassermann, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2014-05-07

Of the 3 recalls from Alfa Wassermann, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-1530-2014·2014-05-07

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2014·2014-05-07

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2013·2013-02-06

    Alfa Wassermann System Diluent Recalled for Inaccurate Calibration Results

    Alfa Wassermann is recalling 4,104 kits of System Diluent because inorganic phosphorus assays may not produce acceptable calibration results.

    Product
    Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Alfa Wassermann (Poland)

company in Warsaw, Poland

Country
Poland
Founded
1948

Official website

Source: Wikidata (Q30268744), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.