The Recall Desk

FDA (Devices) recall action 62894

Instrumentation Laboratory Co. recalled 6 products on 2012-09-26

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2012-09-26
Critical
0
Units
4,297

Why these products were recalled

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

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.

1–6 of 6

  • SevereFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 700 LAS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP 700 Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.

    Product
    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thromb
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of throm
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.

    Product
    Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thr
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-09-26

    Instrumentation Laboratory ACL TOP 500 CTS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
    Category
    Distribution
    0 states