Recall Z-1189-2024 ยท MVU Reagents, Specific, Analyte
Abbott Molecular, Inc.
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;
| Date | Feb 26, 2024 (initiated Feb 1, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated and issued on 2/1/2024 via FedEx priority overnight express mail. The letter explained the background, potential impact, and necessary actions to be taken and contained an appendix listing Impacted Abbott Products and an appendix listing CE products and similar US products. The actions to be taken were to destroy all remaining inventory of the impacted products and contact their local Abbott representative for replacements. If the product has been forwarded to other laboratories, the consignee is requested to inform them of the recall and have them t |
| Quantity | 7 kits |
| Distribution | US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.