Recall Z-1188-2024 ยท OYU Dna-Probe Kit, Human Chromosome
Abbott Molecular, Inc.
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;
| 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 | 16 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.