The Recall Desk

FDA (Devices) recall action 93902

Abbott Molecular, Inc. recalled 3 products on 2024-03-06

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2024-03-06
Critical
0
Units
23

Why these products were recalled

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

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.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2024-03-06

    Abbott Vysis Diagnostic Kits Recalled for U.S. Regulatory Non-Compliance

    Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.

    Product
    In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe,
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2024-03-06

    Abbott M1000 Wash Station Shipped Without U.S. Approval or Registration

    Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.

    Product
    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2024-03-06

    Abbott in-vitro diagnostic kits shipped without U.S. approval or registration

    Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.

    Product
    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
    Category
    Distribution
    8 states