Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit Recalled by Abbott Molecular, Inc. Due to Products that were intended for export only which...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Molecular, Inc. directly.
Affected Products
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;
Quantity: 16 kits
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Molecular, Inc.
Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report