Recall Z-1188-2024— 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 MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;. 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.