Cytocell Aquarius D13S319 Probe Recall: Chromomap Error in Package Insert
Cytocell recalls Aquarius D13S319 Plus Deletion Probe (Model LPH068-A) due to an error in the chromomap on the package insert. Affected units include specific lot numbers.
Lower-risk recall
There is an error in the chromomap on the package insert.
Contact the company
What happened, in plain English
Cytocell is recalling a specific DNA probe product because the package insert contains an error in the chromomap. This error could lead to incorrect genetic analysis results if the probe is used without proper understanding of the labeling. Read more at govinfonow.com/recall/68016-cytocell-aquarius-d13s319-probe-recall-chromomap-error-in-package-insert.
Source Summary by GovInfoNow · govinfonow.com/recall/68016-cytocell-aquarius-d13s319-probe-recall-chromomap-error-in-package-insert · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1843-2019
Cite this page
“Cytocell Aquarius D13S319 Probe Recall: Chromomap Error in Package Insert.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68016-cytocell-aquarius-d13s319-probe-recall-chromomap-error-in-package-insert. Based on FDA recall #Z-1843-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1843-2019%22&limit=1).
Why it’s dangerous
The chromomap error means the probe's labeling might not accurately represent the genetic regions it covers. This could cause misinterpretation of genetic data during testing, but it does not pose a physical risk to users.
Who’s affected
Genetic testing labs and researchers using the Aquarius D13S319 Plus Deletion Probe (Model LPH068-A) are likely affected. Those who have the specific lot numbers listed are at risk of using an incorrect probe.
How to tell if you have this one
Check for the model number LPH068-A on the probe packaging. Affected units have specific lot numbers: 058585, 061111, 061354, or 062527.
- Brand
Cytocell- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot numbers 058585, 061111, 061354, or 062527 on the probe packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Colorado, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Jersey, New York, North Carolina, Tennessee, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1843-2019 (April 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1843-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.