Recall Z-1544-2025 ยท PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
Agilent Technologies, Inc.
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
| Date | Apr 8, 2025 (initiated Mar 20, 2025) |
| Status | Open, Classified |
| Reason | DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/20/2025, "URGENT MEDICAL DEVICE RECALL" notices dated 3/20/2025 were emailed to customers who were asked to do the following: 1. Please check your inventory and identify if you have the affected product. 2. Confirm the number of affected kits in your possession and discard any unused kits. 3. Inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. Please ensure that your organization maintains awareness of this notice. 4. Complete and return the acknowledgement form via email to field |
| Quantity | 70 |
| Distribution | US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163367 | GenetiSure Dx Postnatal Assay Agilent Technologies, Inc., Aug 11, 2017 |