The Recall Desk

FDA (Devices) recall action 81678

Diagnostica Stago, Inc. recalled 2 products on 2018-12-26

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
2018-12-26
Critical
0
Units
44,684

Why these products were recalled

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

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)··2018-12-26

    Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.

    Product
    Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-12-26

    Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability

    Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.

    Product
    Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
    Category
    Distribution
    0 states