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;
Reported: March 6, 2024 Initiated: February 1, 2024 #Z-1188-2024
Product Description
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;
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 16 kits
- Distribution
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Abbott Molecular, Inc.. Units affected: 16 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Low. Recall number: Z-1188-2024.
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