The Recall Desk

FDA (Devices) recall action 80826

Diagnostica Stago, Inc. recalled 2 products on 2018-09-19

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
2018-09-19
Critical
0
Units
24,048

Why these products were recalled

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

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)··2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Plus Reagents Due to Quality Control Failures

    Diagnostica Stago is recalling 24,043 kits of STA N¿oplastine¿ CI Plus reagents because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA¿ - N¿oplastine¿ CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿,
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-09-19

    Diagnostica Stago Recalls STA N¿oplastine¿ CI Reagents Due to Quality Control Issues

    Diagnostica Stago is recalling STA N¿oplastine¿ CI in-vitro diagnostic kits because quality control values fell outside assigned ranges, potentially affecting prothrombin time test results.

    Product
    Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA¿ - N¿oplastine¿ CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R¿, STA Compact¿
    Category
    Distribution
    0 states