Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 16, 2025
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).
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 th…
Agilent Technologies, Inc. recalled GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot… - a moderate-severity action.
GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot… was recalled by Agilent Technologies, Inc. in April 16, 2025. Reason: DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, …. Check the official notice for the remedy. Verify recall #Z-1544-2025 with the FDA Devices before acting.
The recall
Agilent Technologies, Inc. issued this moderate-severity FDA Devices recall-DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, ….
- Moderate
- severity level
- 70 units
- affected scope
- Class II
- classification
- April 16, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1544-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1544-2025) was formally reported on April 16, 2025, with the manufacturer initiating the action on March 20, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Agilent Technologies, Inc. is listed as the recalling firm, operating out of Santa Clara, CA. Federal records list the affected scope as 70.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
70
Related Recalls
6
3 from same agency
Product description
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).
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1544-2025 |
| Date reported | April 16, 2025 |
| Date initiated | March 20, 2025 |
| Recalling firm | Agilent Technologies, Inc. |
| Firm location | Santa Clara, CA |
| Affected scope | 70 |
| Distribution | US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1544-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Agilent Technologies, Inc.. Units affected: 70.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Moderate. Recall number: Z-1544-2025.
Where was the recalled product distributed? ▼
Distribution: US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1544-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 16, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.