Recall Z-1189-2024— Abbott Molecular, Inc.
Class III · Ongoing
Class III FDA medical device recall by Abbott Molecular, Inc., initiated 2024-02-01. FDA's recall record names no specific 510(k) clearance for this event. 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, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;. Reason: 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..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2024-02-01
- Firm location
- Des Plaines, IL, United States
Product description
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;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.