FDAFDA · Food and drugs·Recall number Z-1188-2024
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;
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 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-05; #387021, Exp. 2024-08-01; #528081, exp. 2023-11-16; (2) REF 01N34-020 - GTIN 00884999000766, Lot #522756, Exp. 2023-06-21.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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