FDAFDA · Food and drugs·Recall number Z-1189-2024
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, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;
Published March 6, 2024 · Recall initiated: February 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Molecular, Inc.
- Distributor
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- Lot
- (1) REF 01N33-020 - GTIN 00884999000759, Lot #381411, Exp. 2024-09-22; (2) REF 04N62-020 - GTIN 00884999009301, Lot #382133, Exp. 2024-05-25; (3) REF 05J03-001 - GTIN 00884999009882, Lot #381111, Exp. 2024-06-17; (4) REF 05J03-004 - GTIN 00884999009912, Lot #381102, Exp. 2024-06-17; (5) REF 05J04-022 - GTIN 00884999010451, Lot #530242, Exp. 2024-03-28.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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